Data / Medical devices / Switzerland / Synthes GMBH
Synthes GMBH: FDA-registered device maker in Zuchwil Solothurn, Switzerland, 538 510(k) clearances and 1 PMA approval
Synthes GMBH is registered with the FDA (registration 3009417901) in Zuchwil Solothurn, Switzerland. It lists 166 device types. The FDA files 538 510(k) clearances and 1 PMA approval under its listings, the newest dated June 11, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009417901
- Address
- Luzernstrasse 21, Zuchwil Solothurn, Switzerland, CH-4528
- Owner or operator
- SYNTHES GMBH / Synthes Produktions GmbH (9071542)
- Roles
- Specification developer
- First device listed
- February 24, 1981
- Registered through
- 2027
- Brand names listed
- 2.4/2.7mm VA-LCP Forefoot/Midfoot, 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES, 2.4mm Cannulated Compression Screw, 2.4mm Cannulated Screw, 2.4mm VA LCP Two Column Volar DR, 2.4mm Variable Angle LCP Volar Rim Distal Radius System, 2.7mm VA LCP Clavicle Plate System, 3.5 / 4.5 MM LCP METAPHYSEAL PLATES and more
Devices it lists
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 538.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 11, 2026 | K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | KTT | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| March 10, 2026 | K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | HRS | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| March 9, 2026 | K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | HRS | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| 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 |
| November 12, 2025 | K243715 | Synthes Patient Specific Implants | GXN | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| March 28, 2025 | K241927 | Synthes Graphic Case & Tray System | KCT | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| August 1, 2024 | K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | HSB | Substantially Equivalent | DePuy Synthes | 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 |
| July 26, 2023 | K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | KTT | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| May 19, 2022 | K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | HBC | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| January 28, 2022 | K212943 | SyntheCel Dura Repair | GXQ | Substantially Equivalent | Synthes (USA) Products, LLC | 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 |
| 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 11, 2020 | K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | HRS | Substantially Equivalent | DePuy Synthes | 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 | 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 24, 2020 | K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| April 6, 2020 | K200361 | Akros Scruture Anchor LisFranc Repair Kit | HTN | Substantially Equivalent | Akros Medical | accessdata.fda.gov |
| April 2, 2020 | K192646 | SYMPHONY OCT System | NKG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| November 7, 2019 | K192327 | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| July 19, 2019 | K183545 | Anspach Helix Dissection Tools | HBE | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| July 18, 2019 | K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System | NKG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| May 23, 2019 | K183054 | SYNMESH System | MQP | Substantially Equivalent | Depuy Synthes Spine | 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 |
| December 21, 2018 | K180821 | TruMatch Graft Cage - Long Bone | HRS | Substantially Equivalent | Synthes (Usa), LLC | accessdata.fda.gov |
| December 6, 2018 | K181231 | DePuy Synthes T-PAL Spacer System | MAX | Substantially Equivalent | Depuy Synthes Spine | 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 |
| October 19, 2018 | K180213 | Titanium TomoFix Medial High Tibia Plate Anatomical | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| October 16, 2018 | K182154 | Depuy Synthes Femoral Neck System | KTT | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 11, 2018 | K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System | MQP | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| March 27, 2018 | K180063 | OCM-G1 Attachment | ERL | Substantially Equivalent | The Anspach Effort, Inc. | 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 |
| December 7, 2017 | K170818 | Craniomaxillofacial Distraction System (CMFD) | PBJ | Substantially Equivalent | Synthes USA Products, LLC | 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 |
| May 8, 2017 | K162594 | Craniomaxillofacial Distraction System (CMFD) | MQN | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| March 29, 2017 | K170654 | USS System | NKB | Substantially Equivalent | Synthes USA Products, LLC | 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 |
| February 9, 2017 | K163046 | DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| January 18, 2017 | K153587 | Taps for Resorbable Screws | HBG | 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 |
| 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 |
| November 1, 2016 | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | MAX | 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 |
| July 1, 2016 | K160904 | Expedium Spine System, VIPER and VIPER 2 Systems | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| December 2, 2015 | K152239 | Zero-P Natural Plate System | KWQ | Substantially Equivalent | Synthes (Usa), LLC | 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 |
| August 21, 2015 | K150673 | SYNFIX Evolution Secured Spacer System | OVD | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 23, 2015 | K150796 | Dental Bone Cutting Instruments | DZJ | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 18, 2015 | K151276 | DePuy Synthes T-PAL Ti Spacer | MAX | 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 |
| February 19, 2015 | K142597 | Vienna System | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| January 20, 2015 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | NKG | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| November 18, 2014 | K142587 | Vertical Expandable Prosthetic Titanium Rib | MDI | Substantially Equivalent | Depuy Synthes Spine, Inc. | 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 |
| September 25, 2014 | K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | KWP | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| August 29, 2014 | K141796 | DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM | HRS | 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 | K140462 | MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) | GWO | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| May 2, 2014 | K133616 | MATRIXRIB FIXATION SYSTEM | HRS | Substantially Equivalent | Synthes (USA) Products, 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 16, 2014 | K133698 | SYNAPSE SYSTEM | KWP | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| January 10, 2014 | K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | HBC | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| January 6, 2014 | K131276 | LATERAL SYNFIX | OVD | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| December 31, 2013 | K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | ERL | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| December 16, 2013 | K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | GXQ | Substantially Equivalent | Synthes, 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 5, 2013 | K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM | GWO | Substantially Equivalent | Synthes | accessdata.fda.gov |
| May 24, 2013 | K122639 | SYNTHES SYNCAGE EVOLUTION SPACER | MAX | Substantially Equivalent | Synthes (USA) Products, LLC | 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 |
| February 28, 2013 | K122647 | SYNTHES PATIENT SPECIFIC PLATE | JEY | Substantially Equivalent | Synthes, Inc. | accessdata.fda.gov |
| December 17, 2012 | K122211 | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS | HAW | Substantially Equivalent | Synthes Spine | accessdata.fda.gov |
| November 19, 2012 | K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | JEY | Substantially Equivalent | Synthes, Inc. | accessdata.fda.gov |
| October 19, 2012 | K121876 | VERTECEM II CEMENT KIT | NDN | Substantially Equivalent | Aap Biomaterials GmbH | accessdata.fda.gov |
| August 23, 2012 | K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | MQN | Substantially Equivalent | Synthes, Inc. | accessdata.fda.gov |
| July 31, 2012 | K120838 | SYNTHES MATRIX SYSTEM | NKB | Substantially Equivalent | Synthes Spine | accessdata.fda.gov |
| July 25, 2012 | K121852 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | OVE | Substantially Equivalent | Synthes Spine Co.Lp | 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 29, 2012 | K121574 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | JEY | Substantially Equivalent | Synthes, Inc. | accessdata.fda.gov |
| June 19, 2012 | K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | KWI | Substantially Equivalent | Synthes USA, LLC | accessdata.fda.gov |
| June 18, 2012 | K120854 | SYNTHES VA LCP ANKLE TRAUMA SYSTEM | HRS | 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 |
|---|---|---|---|---|---|---|
| August 14, 2006 | P050010 | PRODISC -L TOTAL DISC REPLACEMENT DEVICE | MJO | 25 | September 2, 2025 | accessdata.fda.gov |
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Updated June 11, 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.