Data / Medical devices / United States / Depuy Orthopaedics

Depuy Orthopaedics: FDA-registered device maker in Bridgewater, MA, United States, 194 510(k) clearances and 1 PMA approval

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

Depuy Orthopaedics is registered with the FDA (registration 3004464325) in Bridgewater, MA, United States. It lists 154 device types. The FDA files 194 510(k) clearances and 1 PMA approval under its listings, the newest dated March 2, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3004464325
Address: 50 Scotland BLVD., Bridgewater, MA, United States, 02324
Owner or operator: DePuy Synthes, Inc. (1818910)
Roles: Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed: December 22, 1977
Registered through: 2027
Brand names listed: 3.5mm Locking Attachment Plates, 6.5mm Midfoot Fusion Bolt, ACE MARKIII ASSEMBLY, ADJUSTABLE LARGE FIXATOR SYSTEM, ARICULATED TENSION DEVICE SYNTHES TEN, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 5 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Repackager or relabeler	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	LXT	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	KTW	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Applier, Staple, Surgical,	GEF	1	Repackager or relabeler	accessdata.fda.gov
Arthroscope	HRX	2	Repackager or relabeler	accessdata.fda.gov
Awl	HWJ	1	Repackager or relabeler	accessdata.fda.gov
Bath, Incubators/Water, All	JTQ	1	Repackager or relabeler	accessdata.fda.gov
Battery, Replacement, Rechargeable	MOQ	1	Repackager or relabeler	accessdata.fda.gov
Bender	HXW	1	Repackager or relabeler	accessdata.fda.gov
Bit, Drill	HTW	1	Repackager or relabeler	accessdata.fda.gov
Bit, Surgical	GFG	1	Repackager or relabeler	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Repackager or relabeler	accessdata.fda.gov
Bone Cement	LOD	2	Repackager or relabeler	accessdata.fda.gov
Bone Grafting Material, Synthetic	LYC	2	Repackager or relabeler	accessdata.fda.gov
Bone Mill	LYS	1	Repackager or relabeler	accessdata.fda.gov
Broach	HTQ	1	Repackager or relabeler	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Repackager or relabeler	accessdata.fda.gov
Burr, Orthopedic	HTT	1	Repackager or relabeler	accessdata.fda.gov
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	OIS	2	Repackager or relabeler	accessdata.fda.gov
Caliper	KTZ	1	Repackager or relabeler	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Repackager or relabeler	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Repackager or relabeler	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Repackager or relabeler	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Repackager or relabeler	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Repackager or relabeler	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Repackager or relabeler	accessdata.fda.gov
Clamp	HXD	1	Repackager or relabeler	accessdata.fda.gov
Component, Traction, Invasive	JEC	2	Repackager or relabeler	accessdata.fda.gov
Countersink	HWW	1	Repackager or relabeler	accessdata.fda.gov
Cover, Burr Hole	GXR	2	Repackager or relabeler	accessdata.fda.gov
Cover, Limb	IPM	1	Repackager or relabeler	accessdata.fda.gov
Crimper, Pin	HXQ	1	Repackager or relabeler	accessdata.fda.gov
Curette	HTF	1	Repackager or relabeler	accessdata.fda.gov
Cutter, Surgical	FZT	1	Repackager or relabeler	accessdata.fda.gov
Cutter, Wire	HXZ	1	Repackager or relabeler	accessdata.fda.gov
Dispenser, Cement	KIH	1	Repackager or relabeler	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Repackager or relabeler	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Repackager or relabeler	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Repackager or relabeler	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Repackager or relabeler	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Repackager or relabeler	accessdata.fda.gov
Driver, Surgical, Pin	GFC	1	Repackager or relabeler	accessdata.fda.gov
Driver, Wire, And Bone Drill, Manual	DZJ	2	Repackager or relabeler	accessdata.fda.gov
Dura Substitute	GXQ	2	Repackager or relabeler	accessdata.fda.gov
Electrode, Needle	GXZ	2	Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
Elevator	HTE	1	Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Repackager or relabeler	accessdata.fda.gov
External Mandibular Fixator And/Or Distractor	MQN	2	Repackager or relabeler	accessdata.fda.gov
Extractor	HWB	1	Repackager or relabeler	accessdata.fda.gov
Extractor, Vacuum, Fetal	HDB	2	Repackager or relabeler	accessdata.fda.gov
Fastener, Plate, Cranioplasty	HBW	2	Repackager or relabeler	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Repackager or relabeler	accessdata.fda.gov
Forceps	HTD	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Wire Holding	HYA	1	Repackager or relabeler	accessdata.fda.gov
Gauge, Depth	HTJ	1	Repackager or relabeler	accessdata.fda.gov
Growing Rod System	PGM	2	Repackager or relabeler	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Repackager or relabeler	accessdata.fda.gov
Hammer, Surgical	FZY	1	Repackager or relabeler	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Repackager or relabeler	accessdata.fda.gov
Hook, Bone	KIK	1	Repackager or relabeler	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Repackager or relabeler	accessdata.fda.gov
Impactor	HWA	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Compression	HWN	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	HSZ	1	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Repackager or relabeler	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Repackager or relabeler	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Repackager or relabeler	accessdata.fda.gov
Lamp, Operating-Room	FQP	2	Repackager or relabeler	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Repackager or relabeler	accessdata.fda.gov
Lavage, Jet	FQH	2	Repackager or relabeler	accessdata.fda.gov
Light Source, Fiberoptic, Routine	FCW	2	Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Instrument	FSQ	2	Repackager or relabeler	accessdata.fda.gov
Mallet	HXL	1	Repackager or relabeler	accessdata.fda.gov
Mallet, Surgical, General & Plastic Surgery	GFJ	1	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical	FTM	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	OWY	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Collagen, Staple Line Reinforcement	OXE	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	OXB	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Metal	EZX	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	PAJ	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Repackager or relabeler	accessdata.fda.gov
Methyl Methacrylate For Cranioplasty	GXP	2	Repackager or relabeler	accessdata.fda.gov
Motor, Drill, Pneumatic	HBB	2	Repackager or relabeler	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Repackager or relabeler	accessdata.fda.gov
Nail, Fixation, Bone	JDS	2	Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Repackager or relabeler	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Repackager or relabeler	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Repackager or relabeler	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Repackager or relabeler	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Osteotome	HWM	1	Repackager or relabeler	accessdata.fda.gov
Osteotome, Manual	GFI	1	Repackager or relabeler	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Repackager or relabeler	accessdata.fda.gov
Plate, Bone	JEY	2	Repackager or relabeler	accessdata.fda.gov
Plate, Cranioplasty, Preformed, Alterable	GWO	2	Repackager or relabeler	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Repackager or relabeler	accessdata.fda.gov
Pliers, Surgical	HTC	1	Repackager or relabeler	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Repackager or relabeler	accessdata.fda.gov
Probe	HXB	1	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, Polymer	KWI	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	NJL	3	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	PKC	2	Manufacturer for export	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Repackager or relabeler	accessdata.fda.gov
Punch, Surgical	LRY	1	Repackager or relabeler	accessdata.fda.gov
Rasp	HTR	1	Repackager or relabeler	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Repackager or relabeler	accessdata.fda.gov
Reamer	HTO	1	Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Fiberoptic	FDG	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Self-Retaining, For Neurosurgery	GZT	2	Repackager or relabeler	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Repackager or relabeler	accessdata.fda.gov
Rongeur	HTX	1	Repackager or relabeler	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Repackager or relabeler	accessdata.fda.gov
Screwdriver	HXX	1	Repackager or relabeler	accessdata.fda.gov
Software For Diagnosis/Treatment	OSN	2	Repackager or relabeler	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Repackager or relabeler	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Repackager or relabeler	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Manual	JEB	1	Repackager or relabeler	accessdata.fda.gov
Tamp	HXG	1	Repackager or relabeler	accessdata.fda.gov
Tap, Bone	HWX	1	Repackager or relabeler	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Repackager or relabeler	accessdata.fda.gov
Template	HWT	1	Repackager or relabeler	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tong, Skull For Traction	HAX	2	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Trephine	HWK	1	Repackager or relabeler	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Repackager or relabeler	accessdata.fda.gov
Wire, Surgical	LRN	2	Repackager or relabeler	accessdata.fda.gov
Wrench	HXC	1	Repackager or relabeler	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 194.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 2, 2026	K254054	VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System	HRS	Substantially Equivalent	Synthes GmbH	accessdata.fda.gov
January 6, 2026	K253178	TRILEAP Plating System	HRS	Substantially Equivalent	Crossroads Extremity Systems	accessdata.fda.gov
March 28, 2025	K241927	Synthes Graphic Case & Tray System	KCT	Substantially Equivalent	Synthes GmbH	accessdata.fda.gov
July 26, 2024	K233994	VOLT Proximal Humerus 3.5 Plating System	HRS	Substantially Equivalent	Synthes GmbH	accessdata.fda.gov
May 9, 2024	K233967	DePuy Synthes MatrixSTERNUM Fixation System	HRS	Substantially Equivalent	Synthes GmbH	accessdata.fda.gov
March 21, 2024	K233665	DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
September 29, 2023	K230591	TriLEAP Plating System	HRS	Substantially Equivalent	Crossroads Extremity Systems	accessdata.fda.gov
October 18, 2022	K213978	TELIGEN System	HRX	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
September 20, 2022	K221809	DePuy Synthes 3.5mm Intrapelvic Acetabular System	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
May 5, 2022	K212756	Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
January 28, 2022	K212943	SyntheCel Dura Repair	GXQ	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 23, 2020	K201346	DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
February 26, 2020	K191463	DePuy Synthes Hammertoe Continuous Compression Implant	JDR	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
May 17, 2019	K183618	Revolution Radial Head	KWI	Substantially Equivalent	Ignite Orthopedics, Inc.	accessdata.fda.gov
May 9, 2019	K181933	DePuy Synthes Sterilization Container System	KCT	Substantially Equivalent	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	accessdata.fda.gov
November 21, 2018	K180541	DePuy Synthes 2.0 mm Quick Insertion Screws	HWC	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
April 5, 2018	K173526	SENTIO MMG Gen 2	PDQ	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
March 22, 2018	K173134	SENTIO MMG Pedicle Access Needles	PDQ	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
December 14, 2017	K173550	Akros FibuLink Syndesmosis Repair Kit	HTN	Substantially Equivalent	Akros Medical	accessdata.fda.gov
November 14, 2017	K172157	DePuy Synthes Femoral Recon Nail System	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 28, 2017	K170802	TRAUMACEM V+ Injectable Bone Cement	LOD	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 14, 2017	K170937	VIPER PRIME navigated inserter	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
August 31, 2017	K171570	Additional VIPER PRIME screws with fenestrations	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
May 4, 2017	K170543	VIPER PRIME Screws with Fenestrations	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
February 16, 2017	K161616	DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw	HWC	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
January 10, 2017	K162805	Akros Fibulink Syndesmosis Repair Kit	HTN	Substantially Equivalent	Akros Medical	accessdata.fda.gov
December 8, 2016	K162912	VIPER PRIME additions to the VIPER® System	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
November 10, 2016	K161417	DePuy Synthes MAXFRAME Multi-Axial Correction System	KTT	Substantially Equivalent	Synthes USA, LLC	accessdata.fda.gov
July 1, 2016	K160904	Expedium Spine System, VIPER and VIPER 2 Systems	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
September 3, 2015	K151885	SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System	NKG	Substantially Equivalent	Depuy Synthes, Inc.	accessdata.fda.gov
June 23, 2015	K150796	Dental Bone Cutting Instruments	DZJ	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
May 11, 2015	K150125	Elite Nitinol Fixation System	JDR	Substantially Equivalent	Biomedical Enterprises, Inc.	accessdata.fda.gov
March 27, 2015	K141385	DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)	HBW	Substantially Equivalent	Depuy Synthes Companies of Johnson & Johnson	accessdata.fda.gov
January 20, 2015	K142838	Synapse Occipital-Cervical-Thoracic (OCT) System	NKG	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
October 24, 2014	K140927	UNIVERSAL NAVIGATION INSTRUMENTS	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
September 25, 2014	K141897	SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM	KWP	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
August 22, 2014	K141509	ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS	PGM	Substantially Equivalent	Medos Sarl	accessdata.fda.gov
August 14, 2014	K130720	SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM	KCT	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
June 13, 2014	K140759	BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL	MAX	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
May 29, 2014	K131304	SENTIO MMG	PDQ	Substantially Equivalent	Innovative Surgical Solutions, LLC ("Iss")	accessdata.fda.gov
May 2, 2014	K133616	MATRIXRIB FIXATION SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
January 9, 2014	K133520	HAMMERLOCK 2	HTY	Substantially Equivalent	Biomedical Enterprises, Inc.	accessdata.fda.gov
December 16, 2013	K131792	SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY	GXQ	Substantially Equivalent	Synthes, Inc.	accessdata.fda.gov
October 11, 2013	K130123	BASIC AND DOMINANT FLEX SUCTION PUMPS	BTA	Substantially Equivalent	Medela AG	accessdata.fda.gov
October 8, 2013	K131186	SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 6, 2013	K132324	SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST	KWQ	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
June 20, 2013	K130877	EXPEDIUM SPINE SYSTEM	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
May 20, 2013	K130146	SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM	NDN	Substantially Equivalent	Synthes (Usa), LLC	accessdata.fda.gov
April 11, 2013	K122455	SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM	KTT	Substantially Equivalent	Synthes	accessdata.fda.gov
December 19, 2012	K123359	OVS1 VIDEO SYSTEM	FCW	Substantially Equivalent	Olive Medical Corp.	accessdata.fda.gov
December 17, 2012	K122211	SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS	HAW	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
December 7, 2012	K122861	XTOOL	HRX	Substantially Equivalent	Ouroboros Medical	accessdata.fda.gov
September 20, 2012	K120867	VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
July 3, 2012	K120966	DEPUY PULSE LUMBAR CAGE SYSTEM	MAX	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
June 19, 2012	K112030	SYNTHES RADIAL HEAD PROSTHESIS SYSTEM	KWI	Substantially Equivalent	Synthes USA, LLC	accessdata.fda.gov
June 14, 2012	K111136	EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM	NKB	Unknown	Depuy Spine, Inc.	accessdata.fda.gov
May 3, 2012	K121020	VIPER SYSTEM	NKB	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
April 26, 2012	K120517	DEPUY PULSE CERVICAL CAGE SYSTEM	ODP	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
February 27, 2012	K113545	VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN	GEI	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company	accessdata.fda.gov
February 8, 2012	K113396	DEPUY PULSE THORACOLUMBAR SCREW SYSTEM	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
January 27, 2012	K113273	SPOTLIGHT ACCESS SYSTEM	GZT	Substantially Equivalent	Johnson & Johnson	accessdata.fda.gov
January 9, 2012	K113071	SYNTHECEL DURA REPLACEMENT DEVICES	GXQ	Substantially Equivalent	Synthes	accessdata.fda.gov
December 5, 2011	K112583	SYNTHES CORTICAL SCREWS	HWC	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
December 5, 2011	K111667	SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS	JDS	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
November 21, 2011	K112724	DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM	KWQ	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
October 11, 2011	K110694	CONCORDE BULLET SPINAL SYSTEM	MAX	Substantially Equivalent	Johnson & Johnson	accessdata.fda.gov
August 10, 2011	K111437	SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)	HTO	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
July 6, 2011	K111571	VIPER SYSTEMS	NKB	Substantially Equivalent	Johnson & Johnson	accessdata.fda.gov
March 2, 2011	K103002	SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM	HSB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
December 7, 2010	K101993	VIPER SYSTEM, EXPEDIUM SYSTEM	NKB	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
December 1, 2010	K101923	CONCORDE CURVE SYSTEM	MAX	Substantially Equivalent	Depuy Spine	accessdata.fda.gov
October 18, 2010	K101933	MODIFICATION TO:EXPEDIUM SPINE SYSTEM	NKB	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
September 24, 2010	K100992	NEURALMAS	ETN	Substantially Equivalent	Innovative Surgical Solutions, LLC ("Iss")	accessdata.fda.gov
September 23, 2010	K102018	NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY	GXP	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
May 11, 2010	K092190	SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS	KTT	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
April 14, 2010	K093361	SYNTHES AIR PEN DRIVE (APD) SYSTEM	HBB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
April 8, 2010	K100676	SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL	HRS	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
March 9, 2010	K093668	SYNTHES MATRIX MIS RODS	NKB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
March 3, 2010	K090658	SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL	KTT	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
December 29, 2009	K092929	SYNTHES MATRIX SYSTEM	NKB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
November 6, 2009	K090605	CLAMPFIX	NKB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
October 22, 2009	K091499	MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)	FTM	Substantially Equivalent	Kensey Nash Corp.	accessdata.fda.gov
June 17, 2009	K090241	SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)	HSB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
June 10, 2009	K090648	VIPER 2 SYSTEM	NKB	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
May 22, 2009	K081917	DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS	MAX	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
April 30, 2009	K082649	SYNTHES 90 DEGREE SCREWDRIVER	DZI	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
March 4, 2009	K083573	SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES	HRS	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
December 11, 2008	K082914	CLAMPFIX	NKB	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
November 24, 2008	K082572	USS ILIOSACRAL, USS POLYAXIAL	NKB	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
November 18, 2008	K082650	SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL	KTT	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
November 14, 2008	K082128	DEPUY SPINE LATERAL CAGE SYSTEM	MAX	Substantially Equivalent	Depuy Spine	accessdata.fda.gov
July 18, 2008	K081452	SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM	HSB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
July 15, 2008	K073115	ORTHOMESH	HRS	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
July 2, 2008	K073303	NORIAN DRILLABLE	OIS	Unknown	Synthes (Usa)	accessdata.fda.gov
May 1, 2008	K081071	SYNTHES 6.5MM MIDFOOT FUSION BOLT	HWC	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
January 25, 2008	K073649	BENGAL STACKABLE CAGE SYSTEM	MQP	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
January 22, 2008	K072736	RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT	ETN	Substantially Equivalent	Rhythmlink International, LLC	accessdata.fda.gov
November 30, 2007	K071667	SYNTHES VECTRA-ONE SYSTEM	KWQ	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
October 23, 2007	K071046	SYNTHES CHRONOS COMPOSITE	MQV	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
August 24, 2007	K071476	SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP	JEC	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
April 12, 1985	P830055	LCS(R) TOTAL KNEE SYSTEM	NJL	355	October 9, 2026	accessdata.fda.gov

Compare with other makers

Updated October 9, 2026. 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.