Data / Medical devices / United States / Stryker Spine

Stryker Spine: FDA-registered device maker in Allendale, NJ, United States, 112 510(k) clearances

Name: Stryker Spine FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Stryker Spine is registered with the FDA (registration 3004024955) in Allendale, NJ, United States. It lists 36 device types. The FDA files 112 510(k) clearances under its listings, the newest dated November 7, 2024. 49 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Stryker Spine

FDA registration number: 3004024955
Address: 2 Pearl Court, Allendale, NJ, United States, 07401
Owner or operator: VB Spine, LLC (10093189)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: April 14, 2025
Registered through: 2026
Brand names listed: AERO-C Cervical Cage System, AVIATOR, AVS AL, AVS ALign, AVS ARIA, AVS ARIA PEEK Spacers, AVS AS, AVS ASL PEEK Spacer System and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Bone Fixation Cerclage, Sublaminar	OWI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Bone Grafting Material, Synthetic	LYC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Growing Rod System	PGM	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, Metal	NQW	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Retractor	GAD	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device - Cervical	PLR	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Spinous Process Plate	PEK	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Template	HWT	1	Manufacturer, Specification developer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 112.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 7, 2024	K242361	OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI	KWQ	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
June 8, 2023	K222684	XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2 Spinal System, ES2 Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
February 14, 2023	K221490	Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer	ODP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
October 19, 2022	K221728	Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate	KWQ	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
August 10, 2020	K201585	Monterey AL Interbody System	OVD	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
October 3, 2019	K190179	SAHARA Stabilization System	OVD	Substantially Equivalent	K2m, Inc.	accessdata.fda.gov
July 25, 2019	K183249	Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage	MAX	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
May 17, 2019	K183381	Navigation Enabled Instruments	OLO	Substantially Equivalent	Stryker	accessdata.fda.gov
December 12, 2018	K182473	PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems	KWQ	Substantially Equivalent	K2m, Inc.	accessdata.fda.gov
July 18, 2018	K181014	Tritanium PL Cage	MAX	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
January 18, 2018	K173476	Tritanium® TL Curved Posterior Lumbar Cage	MAX	Substantially Equivalent	Stryker	accessdata.fda.gov
October 18, 2017	K172034	Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap	OLO	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
October 10, 2017	K172724	XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory	NKB	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
September 6, 2017	K171496	Tritanium C Anterior Cervical Cage	ODP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
July 18, 2017	K171807	ES2 Neuromonitoring Accessory Instruments	PDQ	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
May 16, 2017	K170496	Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory	NKB	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
November 9, 2016	K162262	Tritanium® PL Cage	MAX	Substantially Equivalent	Stryker	accessdata.fda.gov
July 21, 2016	K160955	Tritanium® PL Cage	MAX	Substantially Equivalent	Stryker	accessdata.fda.gov
July 15, 2016	K161407	Ascential IBD PEEKc Spacer	ODP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
July 8, 2016	K160978	LITe BIO Delivery System	FMF	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
February 12, 2016	K153608	Vitoss BiModal Bone Graft Substitute Foam Strip	MQV	Substantially Equivalent	Orthovita, Inc.	accessdata.fda.gov
January 20, 2016	K151726	AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer	MAX	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
December 18, 2015	K153306	Imbibe Needle	KNW	Substantially Equivalent	Orthovita, Inc.	accessdata.fda.gov
December 18, 2015	K152532	AERO -C Cervical Cage System	ODP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
December 2, 2015	K152632	XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory	NKB	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
September 4, 2015	K143597	Navigated XIA 4.5 Polyaxial Screwdriver	OLO	Substantially Equivalent	Stryker Corporate	accessdata.fda.gov
July 9, 2015	K151755	OASYS(r) System	NKG	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
June 9, 2015	K150753	OASYS System	KWP	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
May 12, 2015	K150539	OASYS System	NKG	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
January 26, 2015	K143163	AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System	OVD	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
January 26, 2015	K142237	Aviator Anterior Cervical Plate (ACP) System	KWQ	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
January 15, 2015	K142741	OASYS System	KWP	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
November 19, 2014	K142251	AVS AS PEEK Spacer	ODP	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
November 13, 2014	K142066	AERO-LL LUMBAR CAGE SYSTEM	OVD	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
October 27, 2014	K142114	Xia® Growth Rod Conversion Set	PGM	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
October 21, 2014	K142381	Xia 3 Spinal System	NKB	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
July 16, 2014	K141217	ACCULIF TL AND PL CAGE	MAX	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
July 1, 2014	K140400	ES2 NEUROMONITORING ACCESSORY INSTRUMENTS	ETN	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
June 5, 2014	K140868	STRYKER KWIC NEEDLE	HAW	Substantially Equivalent	Orthovita, Inc.	accessdata.fda.gov
May 30, 2014	K133328	AERO-AL LUMBAR CAGE SYSTEM	OVD	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
May 20, 2014	K140576	Y WIRE 2	HXI	Substantially Equivalent	Safewire, LLC	accessdata.fda.gov
December 17, 2013	K133188	MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
September 12, 2013	K132505	ACCULIF TL AND PL CAGE	MAX	Substantially Equivalent	Coalign Innovations, Inc.	accessdata.fda.gov
December 7, 2012	K122845	ES2 SPINAL SYSTEM MODEL 48280XXXX	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
November 1, 2012	K122637	LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999	FST	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
October 25, 2012	K120869	ANCHOR-L LUMBAR CAGE	OVD	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
August 28, 2012	K113666	XIA 3 SPINAL SYSTEM	NKB	Unknown	Stryker Spine	accessdata.fda.gov
August 20, 2012	K120486	AVS AS PEEK SPACER	ODP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
June 22, 2012	K121342	XIA 4.5 SPINAL SYSTEM	NKB	Unknown	Stryker Corp.	accessdata.fda.gov
April 16, 2012	K113802	ESCALATE LAMINOPLASTY SYSTEM	NQW	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
January 19, 2012	K111719	OASYS SPINAL SYSTEM	KWP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
August 4, 2011	K111478	STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)	NKB	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
April 22, 2011	K102606	AVS ANCHOR-C CERVICAL CAGE SYSTEM	OVE	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
March 4, 2011	K103292	TRIO TRAUMA SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
February 7, 2011	K103173	VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE	MQV	Substantially Equivalent	Orthovita, Inc.	accessdata.fda.gov
November 9, 2010	K101183	MODIFICATION TO: OASYS SYSTEM	KWP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
October 27, 2010	K102545	FM-02 BONE GRAFT SUBSTITUTE	MQV	Substantially Equivalent	Orthovita, Inc.	accessdata.fda.gov
September 27, 2010	K091618	VITOMATRIX	LYC	Substantially Equivalent	Orthovita, Inc.	accessdata.fda.gov
August 12, 2010	K101051	AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX	MAX	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
August 11, 2010	K100865	AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX	MAX	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
July 8, 2010	K101144	MODIFICATION TO:RADIUS SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
March 18, 2010	K093670	MODIFICATION TO: OASYS SYSTEM	MNH	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
December 23, 2009	K093704	AVS PL PEEK SPACERS	MAX	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
December 3, 2009	K092605	XIA 4.5 SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
September 25, 2009	K092631	MANTIS REDUX SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
June 24, 2009	K091291	XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
April 24, 2009	K090816	STRYKER SPINE AVS PL PEEK SPACERS	MAX	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
April 1, 2009	K083393	XIA 3 SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
March 25, 2009	K083562	STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM	KWQ	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
February 27, 2009	K083661	AVS TL PEEK SPACERS	MAX	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
October 7, 2008	K082608	RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
July 28, 2008	K082014	STRYKER SPINE AVS PL PEEK SPACERS	MAX	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
June 17, 2008	K081439	VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE	MQV	Substantially Equivalent	Orthovita, Inc.	accessdata.fda.gov
March 27, 2008	K080758	AVS PL PEEK SPACERS, MODELS 48351 AND 48353	MAX	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
March 6, 2008	K073470	AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX	MAX	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
February 14, 2008	K080143	MODIFICATION TO STRYKER SPINE OASYS SYSTEM	MNI	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
October 5, 2007	K072568	MODIFICATION TO OASYS SYSTEM	KWP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
September 18, 2007	K072184	VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE	MQV	Substantially Equivalent	Orthovita, Inc.	accessdata.fda.gov
August 27, 2007	K071373	STRYKER SPINE XIA III SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
July 13, 2007	K070631	DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
March 22, 2007	K063430	ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM	KWQ	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
November 22, 2006	K062270	RADIUS SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
October 24, 2006	K062853	MODIFICATION TO STRYKER SPINE OASYS SYSTEM	MNI	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
September 19, 2006	K061813	MANTIS SPINAL SYSTEM	MNH	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
August 18, 2006	K062310	REFLEX HYBRID ACP SYSTEM	KWQ	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
August 3, 2006	K061836	AVS ASL PEEK SPACER SYSTEM	MQP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
July 27, 2006	K061854	XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
May 25, 2006	K060506	STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM	MQP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
May 19, 2006	K060979	XIA TITANIUM AND 4.5 SPINAL SYSTEMS	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
April 13, 2006	K060748	MODIFICATION TO XIA 4.5 SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
March 6, 2006	K060361	XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
December 6, 2005	K053115	XIA SPINAL SYSTEM	MNI	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
November 4, 2005	K051205	STRYKER SPINE AVS ASL PEEK SPACER	MQP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
October 11, 2005	K052761	MODIFICATION TO: XIA 4.5 SPINAL SYSTEM	MNI	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
September 21, 2005	K052317	MODIFICATION TO: STRYKER SPINE OASYS SYSTEM	MNI	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
September 8, 2005	K052181	MODIFICATION TO XIA SPINAL SYSTEM	KWP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
July 27, 2005	K050461	XIA 4.5 SPINAL SYSTEM	MNH	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
February 11, 2005	K042571	STRYKER SPINE AVS TL PEEK SPACER	MQP	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
April 16, 2004	K040261	REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM	KWQ	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
February 20, 2004	K032394	STRYKER SPINE OASYS SYSTEM	MNI	Substantially Equivalent	Howmedica Osteonics Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 28, 2025	96349	Class II	Ongoing	Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.	Potential for the gold unlock button to separate from the inserter.	accessdata.fda.gov
August 23, 2024	95274	Class II	Ongoing	AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C	Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.	accessdata.fda.gov
November 1, 2023	93573	Class II	Ongoing	LITe Decompression Snake Arm, REF 48080230	Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.	accessdata.fda.gov
May 18, 2021	88217	Class II	Terminated	Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962	The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.	accessdata.fda.gov
March 11, 2021	87580	Class II	Terminated	Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).	Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.	accessdata.fda.gov
April 1, 2020	85400	Class II	Terminated	Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010	Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.	accessdata.fda.gov
June 18, 2019	83345	Class II	Terminated	Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100	Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.	accessdata.fda.gov
November 28, 2018	81587	Class II	Terminated	Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.	The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.	accessdata.fda.gov
November 26, 2018	81645	Class II	Terminated	Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as dur	Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was observed that some parts exhibited an edge on the intersection between the radius and the diameter of the probe.	accessdata.fda.gov
November 15, 2018	81641	Class II	Terminated	HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE	Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19	accessdata.fda.gov
September 12, 2018	81096	Class II	Terminated	Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the	The firm received complaints related to the locking mechanism on the steerable inserter not functioning as intended. The firm confirmed that the issue is related to lack of lubrication of the instrument. There are two potential hazards associated with the implant pivoting unexpectedly during implant insertion into the disc space. First, if the implant is ini	accessdata.fda.gov
September 8, 2017	79147	Class II	Terminated	AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two component	When the lever of the Insertion Handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.	accessdata.fda.gov
July 26, 2016	74931	Class II	Terminated	AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocance	Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend	accessdata.fda.gov
December 18, 2015	73180	Class II	Terminated	Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.	Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.	accessdata.fda.gov
December 16, 2015	73179	Class II	Terminated	AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubin	There were two potential interference conditions identified with the way the tubing set attaches to the inserter.	accessdata.fda.gov
September 25, 2015	72413	Class II	Terminated	Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.	Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.	accessdata.fda.gov
September 8, 2015	72495	Class II	Terminated	Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.	The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.	accessdata.fda.gov
October 6, 2014	69784	Class II	Terminated	Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors	Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.	accessdata.fda.gov
July 7, 2014	68908	Class II	Terminated	Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbod	Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.	accessdata.fda.gov
December 18, 2013	67388	Class II	Terminated	Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand. It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers impl	Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.	accessdata.fda.gov
September 24, 2013	66657	Class II	Terminated	Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in	Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.	accessdata.fda.gov
May 30, 2013	65777	Class I	Terminated	Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.	Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.	accessdata.fda.gov
December 27, 2012	64313	Class II	Terminated	Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.	Surgeons have experienced unthreading of the screwdrivers outer shafts during use.	accessdata.fda.gov
August 9, 2012	63386	Class II	Terminated	Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 0	Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.	accessdata.fda.gov
July 5, 2012	63272	Class II	Terminated	Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allen	Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.	accessdata.fda.gov
April 25, 2012	62663	Class II	Terminated	The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POS	The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.	accessdata.fda.gov
April 23, 2012	62648	Class II	Terminated	LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thor	Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.	accessdata.fda.gov
January 13, 2012	61723	Class II	Terminated	Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ	Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.	accessdata.fda.gov
January 12, 2012	61766	Not yet classified	Terminated	Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. Product Usage: : Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: The Anti-Torque Key allow	Stryker received four reports regarding a handle which separates at the point where it is welded to the shaft on the Xia 3 Anti-Torque Key during surgery.	accessdata.fda.gov
June 24, 2011	59996	Not yet classified	Terminated	Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA Stryker Mantis Rod Inse	There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter.	accessdata.fda.gov
March 21, 2011	62415	Class II	Terminated	Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an	Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.	accessdata.fda.gov
January 7, 2011	57665	Not yet classified	Terminated	Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following products: Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalog #IS830MAN; Custom T	Stryker Spine has received reports that after sterilization but prior to surgery, cracks were noticed at the tantalum marker / PEI tube interface. This can likely be attributed to differences in the rate of thermal expansion between the markers and the sleeve during the sterilization cycle.	accessdata.fda.gov
December 7, 2010	57462	Not yet classified	Terminated	Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the	Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures.	accessdata.fda.gov
May 13, 2010	55710	Not yet classified	Terminated	Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco	Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the trialling step of the AVS TL procedure.	accessdata.fda.gov
January 18, 2010	54274	Not yet classified	Terminated	Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use	Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.	accessdata.fda.gov
December 30, 2009	54271	Not yet classified	Terminated	Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not Sterile; Manufactured by Stryker Spine, SA, Cestas, France. Distributed in the USA by Stryker Spine, Allendale, NJ Intended for use in the nonc	The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws.	accessdata.fda.gov
October 12, 2009	54169	Not yet classified	Terminated	Stryker Reflex Hybrid Screw Extractor; Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the USA by: Stryker Spine, 2 Pearl Court, Allendale, NJ. The threaded tip of the Reflex Hybrid Screw	The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.	accessdata.fda.gov
October 2, 2009	53606	Not yet classified	Terminated	Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 22MM, spinal implant component	Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.	accessdata.fda.gov
July 1, 2009	52658	Not yet classified	Terminated	Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the USA by: Stryker Spine, Allendale, NJ 07401 The Trio 3.5MM Hex Socket is a reus	The Trio 3.5MM Hex socket has been reported to break under high stresses.	accessdata.fda.gov
April 30, 2009	52090	Not yet classified	Terminated	Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp; 325 Corporate Drive, Mahwah, NJ 07430. The MANTIS Spinal System is intended for poster	The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.	accessdata.fda.gov
August 18, 2008	49441	Not yet classified	Terminated	Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ. The bone screw (Reference # 48694014)	The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.	accessdata.fda.gov
August 18, 2008	49439	Not yet classified	Terminated	Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm diameter x 21 mm long. Ray Cages are indicated for use with autogenous bone graft in patients with Degenerative D	The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.	accessdata.fda.gov
June 5, 2008	48699	Not yet classified	Terminated	Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic su	The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.	accessdata.fda.gov
February 19, 2008	46938	Not yet classified	Terminated	Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal surgery.	The t-bar of the Radius Rod Persuader devices froze due to a loosening screw causing the device to fail.	accessdata.fda.gov
July 10, 2007	38406	Not yet classified	Terminated	Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ 07430	Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod	accessdata.fda.gov
April 12, 2007	52093	Not yet classified	Terminated	Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS, Cestas, France; Distributed by Howmedica Osteonics Corp, Mahwah, NJ 07430 Single use device sterilized prior to u	Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.	accessdata.fda.gov
September 8, 2006	50774	Not yet classified	Terminated	Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800 Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Osteonics Corp., Mahwah, NJ.	DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.	accessdata.fda.gov
September 5, 2006	50753	Not yet classified	Terminated	Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ. The Trio Spinal Fixation Systems are	Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.	accessdata.fda.gov
June 14, 2006	50783	Not yet classified	Terminated	Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp. Mahwah, NJ 07430.	Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.	accessdata.fda.gov

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Updated March 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.