Data / Medical devices / United States / DePuy Synthes Sales

DePuy Synthes Sales: FDA-registered device maker in Bridgewater, MA, United States, 274 510(k) clearances

Name: DePuy Synthes Sales FDA registration, clearances, approvals and recalls
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License: https://creativecommons.org/licenses/by/4.0/

DePuy Synthes Sales is registered with the FDA (registration 3034676720) in Bridgewater, MA, United States. It lists 130 device types. The FDA files 274 510(k) clearances under its listings, the newest dated October 14, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3034676720
Address: 75 Fruit St, Bridgewater, MA, United States, 02324
Owner or operator: SYNTHES (USA) Products LLC (2520274)
Roles: Repackager or relabeler
First device listed: March 16, 1978
Registered through: 2027
Brand names listed: 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM, 2.4/2.7mm VA-LCP Forefoot/Midfoot, 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES, 2.4mm VA LCP Volar DR Plates, 2.4mm VA-LCP Intercarpal Fusion System, 2.7/3.5 LCP Distal Fibula Plates, 2.7/3.5 VA-LCP Anterior Clavicle Plate Sytem, 2.7MM LCP ULNA OSTEOTOMY SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	1	Repackager or relabeler	accessdata.fda.gov
Anchor, Suture, Bone Fixation, Metallic	NOV	2	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	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	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
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
Caliper	KTZ	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Repackager or relabeler	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Repackager or relabeler	accessdata.fda.gov
Chisel, Bone, Surgical	EML	1	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
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Repackager or relabeler	accessdata.fda.gov
Component, Traction, Invasive	JEC	2	Repackager or relabeler	accessdata.fda.gov
Condylar Plate Fixation Implant	JDP	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
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
Device, Fixation, Proximal Femoral, Implant	JDO	2	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 (Manual)	HBG	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
Elevator	HTE	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
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Repackager or relabeler	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	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
Gauge, Depth	HTJ	1	Repackager or relabeler	accessdata.fda.gov
Goniometer, Nonpowered	KQW	1	Repackager or relabeler	accessdata.fda.gov
Gouge, Surgical, General & Plastic Surgery	GDH	1	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
Implant, Endosseous, Orthodontic	OAT	2	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, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Repackager or relabeler	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Repackager or relabeler	accessdata.fda.gov
Mallet	HXL	1	Repackager or relabeler	accessdata.fda.gov
Methyl Methacrylate For Cranioplasty	GXP	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
Ophthalmic Needle	QYM	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	Repackager or relabeler	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Repackager or relabeler	accessdata.fda.gov
Osteotome	HWM	1	Repackager or relabeler	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Repackager or relabeler	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	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, Condyle, Mandibular, Temporary	NEI	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, Polymer	KWI	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Repackager or relabeler	accessdata.fda.gov
Rasp	HTR	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
Sacroiliac Joint Fixation	OUR	2	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
Screwdriver, Skullplate	GXL	1	Repackager or relabeler	accessdata.fda.gov
Software For Diagnosis/Treatment	OSN	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
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	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	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical	LRP	1	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
Twister, Wire	HXS	1	Repackager or relabeler	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Repackager or relabeler	accessdata.fda.gov
Washer, Bolt, Nut, Non-Spinal, Metallic	NDG	2	Repackager or relabeler	accessdata.fda.gov
Wire, Fixation, Intraosseous	DZK	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 274.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 14, 2025	K253010	Mini Superhawk Suture Anchor System	MBI	Substantially Equivalent	Responsive Arthroscopy, LLC	accessdata.fda.gov
March 28, 2025	K241927	Synthes Graphic Case & Tray System	KCT	Substantially Equivalent	Synthes GmbH	accessdata.fda.gov
February 5, 2025	K243790	GRYPHON X Anchor; HEALIX TRANSTEND Anchor	MAI	Substantially Equivalent	Depuy Mitek	accessdata.fda.gov
September 11, 2024	K241010	HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors	MAI	Substantially Equivalent	Depuy Mitek	accessdata.fda.gov
August 1, 2024	K233696	DePuy Synthes Retrograde Femoral Nail Advanced System	HSB	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
June 17, 2024	K233256	Robotic Integration Instruments	OLO	Substantially Equivalent	DePuy Synthes	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
October 18, 2023	K230951	Terumo Injection Filter Needle (NF-3013RBKE05M)	QYM	Substantially Equivalent	Terumo Europe N.V.	accessdata.fda.gov
September 29, 2023	K230591	TriLEAP Plating System	HRS	Substantially Equivalent	Crossroads Extremity Systems	accessdata.fda.gov
July 26, 2023	K231922	DEPUY SYNTHES MAXFRAME AUTOSTRUT System	KTT	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
September 20, 2022	K221809	DePuy Synthes 3.5mm Intrapelvic Acetabular System	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
January 28, 2022	K212943	SyntheCel Dura Repair	GXQ	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
August 5, 2021	K211657	EMPHASYS Femoral Stems	LZO	Substantially Equivalent	Depuy Ireland UC	accessdata.fda.gov
June 2, 2021	K211051	DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
April 8, 2021	K210408	DePuy Synthes Variable Angle Locking Patella Plating System	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
March 26, 2021	K210205	DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
March 18, 2021	K203186	DYNATAPE Suture	GAT	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
January 6, 2021	K202810	AutoStrut G2	KTT	Substantially Equivalent	Orthospin, Ltd.	accessdata.fda.gov
December 16, 2020	K203414	DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System	HRS	Substantially Equivalent	DePuy Synthes	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
September 10, 2020	K201944	DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)	JEY	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 9, 2020	K202153	Responsive Arthroscopy Suture Anchor System	MBI	Substantially Equivalent	Responsive Arthroscopy, LLC	accessdata.fda.gov
September 9, 2020	K201578	DePuy Synthes Variable Angle Locking Patella Plating System	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 3, 2020	K201336	DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm	JDS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
July 31, 2020	K200791	Navigation Enabled Intruments	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
June 4, 2020	K200949	HEALIX ADVANCE Anchor with DYNATAPE Suture	MBI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
April 24, 2020	K200245	EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System	NKB	Substantially Equivalent	Medos International Sàrl	accessdata.fda.gov
April 2, 2020	K192646	SYMPHONY OCT System	NKG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
February 26, 2020	K191463	DePuy Synthes Hammertoe Continuous Compression Implant	JDR	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
November 26, 2019	K192745	DePuy Synthes Trauma Screws	HWC	Substantially Equivalent	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	accessdata.fda.gov
June 21, 2019	K190750	DePuy Synthes Plates and Screws Portfolio	HRS	Substantially Equivalent	DePuy Synthes	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
May 3, 2019	K190409	MatrixRIB Fixation System	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
March 13, 2019	K183113	DePuy Synthes Maxillofacial Portfolio - MR Conditional	MQN	Substantially Equivalent	Synthes (USA) Products, LLC	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
November 1, 2018	K180310	DePuy Synthes Trauma Orthopedic Plates and Screws	HRS	Substantially Equivalent	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	accessdata.fda.gov
August 2, 2018	K181182	DYNACORD Suture	GAT	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
April 11, 2018	K173859	HEALIX ADVANCE Anchor with DYNACORD Suture	MAI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
March 5, 2018	K172872	DePuy Synthes Femoral Neck System	KTT	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
December 14, 2017	K173550	Akros FibuLink Syndesmosis Repair Kit	HTN	Substantially Equivalent	Akros Medical	accessdata.fda.gov
November 27, 2017	K171114	HEALIX ADVANCE KNOTLESS Anchor	MAI	Substantially Equivalent	Medos International SARL	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
June 30, 2017	K160553	DePuy Synthes 4.0 mm and 5.0 mm Locking Screws MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Modular Foot System MR Conditional, DePuy Synthes T-Plates MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) MR Conditional, DePuy Synthes Stainless S	HRS	Substantially Equivalent	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	accessdata.fda.gov
May 8, 2017	K162594	Craniomaxillofacial Distraction System (CMFD)	MQN	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
May 4, 2017	K170543	VIPER PRIME Screws with Fenestrations	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
March 29, 2017	K162124	Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins	JDP	Substantially Equivalent	DePuy Synthes	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 18, 2017	K153587	Taps for Resorbable Screws	HBG	Substantially Equivalent	Synthes (USA) Products, LLC	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
November 3, 2016	K161590	MatrixRIB Fixation System	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 26, 2016	K160167	DePuy Synthes TFNA Augmentation System	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
February 26, 2016	K153575	Tyber Medical Trauma Screw	HWC	Substantially Equivalent	Tyber Medical, LLC	accessdata.fda.gov
October 6, 2015	K150209	Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc	MAI	Substantially Equivalent	Depuy Mitek, A Johnson and Johnson Company	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 30, 2015	K141527	DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM	HRS	Substantially Equivalent	Synthes USA	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
March 23, 2015	K150099	Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
November 19, 2014	K142185	EXPEDIUM VERSE SPINE SYSTEM	NKB	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
November 17, 2014	K142292	Speed, Speed Shift, Speed Titan, Speed Arc	JDR	Substantially Equivalent	Biomedical Enterprises, Inc.	accessdata.fda.gov
October 24, 2014	K140927	UNIVERSAL NAVIGATION INSTRUMENTS	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
October 17, 2014	K141165	MATRIXWAVE MMF SYSTEM	JEY	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
October 1, 2014	K142460	EXPEDIUM Spine System/Synapse System	KWP	Substantially Equivalent	Johnson and Johnson	accessdata.fda.gov
August 29, 2014	K141796	DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
June 13, 2014	K140462	MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)	GWO	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
April 7, 2014	K133844	SPEED TRIAD	JDR	Substantially Equivalent	Biomedical Ent., Inc.	accessdata.fda.gov
March 20, 2014	K133842	TYBER MEDICAL TRAUMA SCREW	HWC	Substantially Equivalent	Tyber Medical, LLC	accessdata.fda.gov
February 28, 2014	K131548	SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
January 9, 2014	K133520	HAMMERLOCK 2	HTY	Substantially Equivalent	Biomedical Enterprises, Inc.	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 12, 2013	K131802	EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM	OSH	Substantially Equivalent	Depuy Spine, A Johnson & Johnson Company	accessdata.fda.gov
September 5, 2013	K123723	SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM	GWO	Substantially Equivalent	Synthes	accessdata.fda.gov
June 20, 2013	K130877	EXPEDIUM SPINE SYSTEM	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
April 11, 2013	K122455	SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM	KTT	Substantially Equivalent	Synthes	accessdata.fda.gov
September 20, 2012	K120867	VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
August 23, 2012	K121502	SYNTHES CURVILINEAR DISTRACTION SYSTEM	MQN	Substantially Equivalent	Synthes, Inc.	accessdata.fda.gov
July 6, 2012	K121601	SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
July 6, 2012	K120807	SYNTHES MULTILOC HUMERAL NAILING SYSTEM	HSB	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
June 18, 2012	K120854	SYNTHES VA LCP ANKLE TRAUMA SYSTEM	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
June 14, 2012	K111136	EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM	NKB	Unknown	Depuy Spine, Inc.	accessdata.fda.gov
June 4, 2012	K120689	SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
May 8, 2012	K120717	SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
March 21, 2012	K120070	SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
February 29, 2012	K113364	2.7MM LCP ULNA OSTEOTOMY SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	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 17, 2011	K112085	SYNTHES LCP PEDIATRIC PLATE SYSTEMS	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
August 10, 2011	K111437	SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)	HTO	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
July 28, 2011	K110789	SYNTHES STERNAL ZIPFIX SYSTEM	JDQ	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
May 24, 2011	K111230	SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW	HWC	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
April 21, 2011	K110125	2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
April 1, 2011	K110216	EXPEDIUM SYSTEM, VIPER SYSTEM	NKB	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
March 4, 2011	K110354	4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM	JDP	Substantially Equivalent	Synthes USA	accessdata.fda.gov

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Updated October 14, 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.