Data / Medical devices / Switzerland / SYNTHES GMBH / Synthes Produktions GmbH
SYNTHES GMBH / Synthes Produktions GmbH: FDA-registered device maker in Oberdorf, Baselland Basel-Landschaft, Switzerland, 25 510(k) clearances
SYNTHES GMBH / Synthes Produktions GmbH is registered with the FDA (registration 8030965) in Oberdorf, Baselland Basel-Landschaft, Switzerland. It lists 34 device types. The FDA files 25 510(k) clearances under its listings, the newest dated January 6, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 8030965
- FEI number
- 3002807305
- Address
- Eimattstrasse 3, Oberdorf, Baselland Basel-Landschaft, Switzerland, CH-4436
- Owner or operator
- SYNTHES GMBH / Synthes Produktions GmbH (9071542)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 24, 1981
- Registered through
- 2027
- Brand names listed
- BIT, DRILL, DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS), DePuy Synthes Femoral Recon Nail System, DePuy Synthes Hammertoe Continuous Compression Implant, EXTRACTOR, FILLER, BONE VOID, CALCIUM COMPOUND, HAMMERLOCK 2, Irrigation clips 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2026 | K253178 | TRILEAP Plating System | HRS | Substantially Equivalent | Crossroads Extremity Systems | accessdata.fda.gov |
| September 29, 2023 | K230591 | TriLEAP Plating System | HRS | Substantially Equivalent | Crossroads Extremity Systems | accessdata.fda.gov |
| February 26, 2020 | K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | JDR | 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 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 |
| November 17, 2014 | K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | JDR | Substantially Equivalent | Biomedical Enterprises, Inc. | accessdata.fda.gov |
| April 17, 2014 | K133270 | SPEED ARC | JDR | Substantially Equivalent | Biomedical Enterprises, Inc. | accessdata.fda.gov |
| April 7, 2014 | K133844 | SPEED TRIAD | JDR | Substantially Equivalent | Biomedical Ent., Inc. | accessdata.fda.gov |
| March 19, 2014 | K133780 | SPEED XL | JDR | Substantially Equivalent | Biomedical Ent., Inc. | accessdata.fda.gov |
| January 9, 2014 | K133520 | HAMMERLOCK 2 | HTY | Substantially Equivalent | Biomedical Enterprises, Inc. | accessdata.fda.gov |
| May 14, 2013 | K124022 | SPEED SHIFT | JDR | Substantially Equivalent | Biomedical Enterprises, Inc. | accessdata.fda.gov |
| April 14, 2010 | K093361 | SYNTHES AIR PEN DRIVE (APD) SYSTEM | HBB | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| June 17, 2009 | K090241 | SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) | HSB | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| April 30, 2009 | K082649 | SYNTHES 90 DEGREE SCREWDRIVER | DZI | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| July 15, 2008 | K073115 | ORTHOMESH | HRS | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| February 27, 2007 | K062789 | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM | JEY | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| January 23, 2006 | K053022 | SYNTHES (USA) CHRONOS-BETA-TCP | LYC | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| January 7, 2005 | K043045 | SYNTHES (USA) CHRONOS | MQV | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| January 5, 2005 | K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | HWE | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| September 8, 2004 | K041611 | SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP | GXR | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| July 8, 2004 | K041350 | SYNTHES (USA) CHRONOS | GXP | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| April 8, 2003 | K030069 | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM | JEY | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| November 26, 2002 | K013072 | CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) | MQV | Substantially Equivalent | Synthes | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 16, 2020 | 85951 | Class II | Terminated | MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and | One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm). | accessdata.fda.gov |
Compare with other makers
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Staple, Fixation, Bone
- All makers of Plate, Bone
- All makers of Instrument, Bending Or Contouring
Updated January 6, 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.