Synthes (USA) Products LLC
West Chester, PA, US
Synthes (USA) Products LLC appears in FDA device records in West Chester, PA. FDA records list 479 510(k) clearances between and , 4 PMA records and one registered establishment. As of , FDA records show 168 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Synthes (USA) Products LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Synthes USA, LLC510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 479FDA records hold 479 510(k) clearances for Synthes (USA) Products LLC between 1977 and 2026. The busiest year on record is 2003, with 36. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 3 |
| 1980 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 5 |
| 1993 | 8 |
| 1994 | 5 |
| 1995 | 10 |
| 1996 | 27 |
| 1997 | 19 |
| 1998 | 19 |
| 1999 | 15 |
| 2000 | 23 |
| 2001 | 33 |
| 2002 | 26 |
| 2003 | 36 |
| 2004 | 35 |
| 2005 | 31 |
| 2006 | 14 |
| 2007 | 18 |
| 2008 | 25 |
| 2009 | 19 |
| 2010 | 16 |
| 2011 | 15 |
| 2012 | 10 |
| 2013 | 5 |
| 2014 | 11 |
| 2015 | 8 |
| 2016 | 4 |
| 2017 | 7 |
| 2018 | 5 |
| 2019 | 5 |
| 2020 | 6 |
| 2021 | 3 |
| 2022 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System | KTT | Substantially Equivalent | |
| K212943 | SyntheCel Dura Repair | GXQ | Substantially Equivalent | |
| K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | KTT | Substantially Equivalent | |
| K210408 | DePuy Synthes Variable Angle Locking Patella Plating System | HRS | Substantially Equivalent | |
| K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System | HRS | Substantially Equivalent | |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm | HSB | Substantially Equivalent | |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | GXN | Substantially Equivalent | |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | JEY | Substantially Equivalent | |
| K201578 | DePuy Synthes Variable Angle Locking Patella Plating System | HRS | Substantially Equivalent | |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm | JDS | Substantially Equivalent | |
| K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | JDR | Substantially Equivalent | |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | JEY | Substantially Equivalent | |
| K192327 | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile | HRS | Substantially Equivalent | |
| K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional | HRS | Substantially Equivalent | |
| K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional | FTM | Substantially Equivalent | |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | MQN | Substantially Equivalent | |
| K180821 | TruMatch Graft Cage - Long Bone | HRS | Substantially Equivalent | |
| K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | HWC | Substantially Equivalent | |
| K180213 | Titanium TomoFix Medial High Tibia Plate Anatomical | HRS | Substantially Equivalent | |
| K182154 | Depuy Synthes Femoral Neck System | KTT | Substantially Equivalent | |
| K180544 | DePuy Synthes Static Staples | JDR | Substantially Equivalent | |
| K170818 | Craniomaxillofacial Distraction System (CMFD) | PBJ | Substantially Equivalent | |
| K172157 | DePuy Synthes Femoral Recon Nail System | HSB | Substantially Equivalent | |
| K170802 | TRAUMACEM™ V+ Injectable Bone Cement | LOD | Substantially Equivalent | |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | MQN | Substantially Equivalent | |
| K170654 | USS System | NKB | Substantially Equivalent | |
| 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 | |
| K153587 | Taps for Resorbable Screws | HBG | Substantially Equivalent | |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | KTT | Substantially Equivalent | |
| K161590 | MatrixRIB Fixation System | HRS | Substantially Equivalent | |
| K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | MAX | Substantially Equivalent | |
| K160167 | DePuy Synthes TFNA Augmentation System | HSB | Substantially Equivalent | |
| K152239 | Zero-P Natural Plate System | KWQ | Substantially Equivalent | |
| K150673 | SYNFIX Evolution Secured Spacer System | OVD | Substantially Equivalent | |
| K150796 | Dental Bone Cutting Instruments | DZJ | Substantially Equivalent | |
| K151276 | DePuy Synthes T-PAL Ti Spacer | MAX | Substantially Equivalent | |
| K143285 | Mandible External Fixator - MR Conditional | MQN | Substantially Equivalent | |
| K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM | HRS | Substantially Equivalent | |
| K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) | HRS | Substantially Equivalent | |
| K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | NKG | Substantially Equivalent | |
| K141165 | MATRIXWAVE MMF SYSTEM | JEY | Substantially Equivalent | |
| K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | KWP | Substantially Equivalent | |
| K141796 | DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM | HRS | Substantially Equivalent | |
| K130720 | SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | |
| K141241 | MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM | HRS | Substantially Equivalent | |
| K140462 | MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) | GWO | Substantially Equivalent | |
| K133616 | MATRIXRIB FIXATION SYSTEM | HRS | Substantially Equivalent | |
| K131984 | SYNTHES SYNSONIC ULNA NAIL | HSB | Substantially Equivalent | |
| K131548 | SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM | HSB | Substantially Equivalent | |
| K133698 | SYNAPSE SYSTEM | KWP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008812560 | 3008812560 | Synthes (USA) Products LLC | 1301 Goshen Pkwy, West Chester, PA 19380 US | 2026 | and 163 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HSTApparatus, Traction, Non-Powered
- HRXArthroscope
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- GFFBur, Surgical, General & Plastic Surgery
- GEACannula, Surgical, General & Plastic Surgery
- GBXCatheter, Irrigation
- EMLChisel, Bone, Surgical
- FZOChisel, Surgical, Manual
- GDJClamp, Surgical, General & Plastic Surgery
- GXRCover, Burr Hole
- FZTCutter, Surgical
- GDIDissector, Surgical, General & Plastic Surgery
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- GFCDriver, Surgical, Pin
- DZJDriver, Wire, And Bone Drill, Manual
- GXQDura Substitute
- BXBExerciser, Powered
- HBWFastener, Plate, Cranioplasty
- GENForceps, General & Plastic Surgery
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDZHandle, Scalpel
- GDGHook, Surgical, General & Plastic Surgery
- HBXInstrument, Cranioplasty Material Forming
- HCFInstrument, Ligature Passing And Knot Tying
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- FQPLamp, Operating-Room
- DYXLock, Wire, And Ligature, Intraoral
- FTMMesh, Surgical
- EZXMesh, Surgical, Metal
- FTLMesh, Surgical, Polymeric
- GXPMethyl Methacrylate For Cranioplasty
- HBBMotor, Drill, Pneumatic
- GEYMotor, Surgical Instrument, Ac-Powered
- GAANeedle, Aspiration And Injection, Disposable
- HAWNeurological Stereotaxic Instrument
- GFIOsteotome, Manual
- GWOPlate, Cranioplasty, Preformed, Alterable
- GXNPlate, Cranioplasty, Preformed, Non-Alterable
- HRSPlate, Fixation, Bone
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- CANRegulator, Pressure, Gas Cylinder
- GADRetractor
- FDGRetractor, Fiberoptic
- HSBRod, Fixation, Intramedullary And Accessories
- GDXScalpel, One-Piece
- DZLScrew, Fixation, Intraosseous
- GXLScrewdriver, Skullplate
- GAHStylet, Surgical, General & Plastic Surgery
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- GASSuture, Nonabsorbable, Synthetic, Polyester
- FMFSyringe, Piston
- FTYTape, Measuring, Rulers And Calipers
- FSMTray, Surgical, Instrument
- DZKWire, Fixation, Intraosseous
Recall records
Showing 25 of 168| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1703-2026 | 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. | Class II | Open, Classified | |
| Z-1702-2026 | 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. | Class II | Open, Classified | |
| Z-0229-2026 | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System. | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. | Class II | Open, Classified | |
| Z-0228-2026 | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System. | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. | Class II | Open, Classified | |
| Z-1916-2024 | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010 | Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay | Class II | Open, Classified | |
| Z-1242-2024 | Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S | Products not sterilized, sterility cannot be confirmed | Class II | Open, Classified | |
| Z-1241-2024 | VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S | Products not sterilized, sterility cannot be confirmed | Class II | Open, Classified | |
| Z-1240-2024 | TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S | Products not sterilized, sterility cannot be confirmed | Class II | Open, Classified | |
| Z-1239-2024 | TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S | Products not sterilized, sterility cannot be confirmed | Class II | Open, Classified | |
| Z-1238-2024 | RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S | Products not sterilized, sterility cannot be confirmed | Class II | Open, Classified | |
| Z-1237-2024 | RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis. Part Number: 314.746S | Products not sterilized, sterility cannot be confirmed | Class II | Open, Classified | |
| Z-1236-2024 | 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S | Products not sterilized, sterility cannot be confirmed | Class II | Open, Classified | |
| Z-1235-2024 | 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S | Products not sterilized, sterility cannot be confirmed | Class II | Open, Classified | |
| Z-1234-2024 | 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S | Products not sterilized, sterility cannot be confirmed | Class II | Open, Classified | |
| Z-1248-2023 | TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length | Class II | Open, Classified | |
| Z-1247-2023 | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length | Class II | Open, Classified | |
| Z-1246-2023 | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length | Class II | Open, Classified | |
| Z-0101-2023 | DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. | Class II | Open, Classified | |
| Z-0100-2023 | SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. | Class II | Open, Classified | |
| Z-0099-2023 | SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. | Class II | Open, Classified | |
| Z-0098-2023 | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery. | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. | Class II | Open, Classified | |
| Z-0008-2023 | Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound | Class II | Open, Classified | |
| Z-1072-2022 | Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length. | DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis. | Class II | Open, Classified | |
| Z-0634-2022 | Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001 | Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection. | Class II | Open, Classified | |
| Z-0587-2021 | DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain