Manufacturer registered with FDA
SYNTHES GMBH / Synthes Produktions GmbH
West Chester, PA, United States. Lists 8 dental device types with FDA across 3 registered establishments, and holds 5 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 30
- 510(k) clearances
- 52011–2013
- Markets registered in
- 7827 registrations outside the US
- Establishments
- 3Switzerland
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name SYNTHES GMBH / Synthes Produktions GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | SYNTHES GMBH / Synthes Produktions GmbH | 5 clearances | 2011–2013 | Below |
| Peru | DIGEMID | Manufacturer | SYNTHES GmbHSYNTHES GMBH · SYNTHES GmBH | 453 | 2013–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SYNTHES GMBHSYNTHES · Synthes GmbH | 171 | 1990–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SYNTHES GMBHSYNTHES GMBH/SYNTHES PRODUKTIONS GMBH | 97 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Synthes GmbhSynthes GmbH | 86 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SYNTHES GMBH | 19 | 2015–2023 | Pure Global AI |
| Egypt | EDA | Manufacturer | Synthes GmbH,, Synthes Produktions GmbH,, | 1 | 2020–2020 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What SYNTHES GMBH / Synthes Produktions GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | MatrixORTHOGNATHIC Plating SystemplatePLATE, BONESYNTHES (USA) [SYNTHES] MINI EXTERNSYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEMSYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEMSynthes MatrixMANDIBLE Preformed ReSynthes MatrixMANDIBLE Preformed Reconstruction PlatesSynthes Neuro Plate and Screw SystemSYNTHES POLY (L-LACTIDE-CO-GLYCOLID | 2008 |
| External Mandibular Fixator and/or DistractorMQN · Class 2 | Maxillofacial plates & screws | Maker | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTORMANDIBLE EXTERNAL FIXATORMINI LENGTHENING APPARATUSSYNTHES (USA) ALVEOLAR RIDGE DISTRASynthes Curvilinear Distraction SystemSYNTHES MANDIBLE DISTRACTOR | 2008 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | SCREW, FIXATION, INTRAOSSEOUSSYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORSYNTHES 1.5MM/2MM ORTHOGNATHIC MASYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEMSYNTHES TITANIUM MULTI-VECTOR DISTRACTOR | 2008 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | SYNTHES (USA) ELECTRIC PEN DRIVE SYSynthes 90 Degree Screwdriver | 2008 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | Dental Bone Cutting InstrumentsSynthes 90 Degree Screwdriver | 2009 |
| Temporary Mandibular Condyle ProsthesisNEI · Class 2 | — | Maker | Condylar Head Add-on-SystemLOCKING RECONSTRUCTIONSYNTHES (USA) CONDYLAR HEAD ADD-ON | 2006 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | chisel | 1996 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | bone grafting material | 2006 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names SYNTHES GMBH / Synthes Produktions GmbH as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Feb 2013 | K122647 | SYNTHES PATIENT SPECIFIC PLATE | JEY Bone Plate |
| 19 Nov 2012 | K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | JEY Bone Plate |
| 23 Aug 2012 | K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | MQN External Mandibular Fixator and/or Distractor |
| 29 Jun 2012 | K121574 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | JEY Bone Plate |
| 21 Dec 2011 | K113251 | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES | JEY Bone Plate |
Some of these clearances are listed with FDA today by another company: SYNTHES (USA) Products LLC (5).
Also lists devices cleared under other names
SYNTHES GMBH / Synthes Produktions GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Synthes (Usa) (56), SYNTHES (USA) Products LLC (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 Sep 2020 | K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | SYNTHES (USA) Products LLC | JEY Bone Plate |
| 8 May 2017 | K162594 | Craniomaxillofacial Distraction System (CMFD) | SYNTHES (USA) Products LLC | MQN External Mandibular Fixator and/or Distractor |
| 23 Jun 2015 | K150796 | Dental Bone Cutting Instruments | SYNTHES (USA) Products LLC | DZJ Manual Wire Driver and Bone Drill |
| 17 Oct 2014 | K141165 | MATRIXWAVE MMF SYSTEM | SYNTHES (USA) Products LLC | JEY Bone Plate |
| 20 Dec 2010 | K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 11 Dec 2009 | K091233 | SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES | Synthes (Usa) | JEY Bone Plate |
| 25 Aug 2009 | K091144 | SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES | Synthes (Usa) | JEY Bone Plate |
| 30 Apr 2009 | K082649 | SYNTHES 90 DEGREE SCREWDRIVER | Synthes (Usa) | DZI Powered Bone Drill |
| 12 Mar 2009 | K083388 | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 10 Nov 2008 | K082335 | SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 5 Sep 2008 | K081747 | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) | NEI Temporary Mandibular Condyle Prosthesis |
| 14 May 2008 | K080153 | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 30 Apr 2008 | K080331 | SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 16 Apr 2007 | K063790 | THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 27 Feb 2007 | K062789 | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 5 Jan 2007 | K063181 | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) | NEI Temporary Mandibular Condyle Prosthesis |
| 31 Aug 2006 | K062299 | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 2 Jun 2006 | K060138 | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 23 Jan 2006 | K053022 | SYNTHES (USA) CHRONOS-BETA-TCP | Synthes (Usa) | LYC Synthetic Bone Grafting Material |
| 18 May 2005 | K050608 | SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 12 Apr 2005 | K043555 | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 6 Apr 2005 | K050606 | SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 15 Mar 2005 | K050378 | SYNTHES MANDIBLE EXTERNAL FIXATOR | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 18 Nov 2004 | K042365 | SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 19 Aug 2004 | K041887 | SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 14 Apr 2004 | K040169 | SYNTHES MANDIBLE EXTERNAL FIXATOR | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 31 Mar 2004 | K040083 | SYNTHES EXTERNAL MIDFACE DISTRACTOR | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 23 Feb 2004 | K040272 | SYNTHES (USA) CRANIOFACIAL PLATES | Synthes (Usa) | JEY Bone Plate |
| 20 Oct 2003 | K033121 | 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES | Synthes (Usa) | JEY Bone Plate |
| 9 Oct 2003 | K033160 | SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES | Synthes (Usa) | JEY Bone Plate |
| 3 Sep 2003 | K031761 | SYNTHES (USA) NEW/STERIAL ORBITAL PLATES | Synthes (Usa) | JEY Bone Plate |
| 2 Jul 2003 | K031807 | SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 8 Apr 2003 | K030069 | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 1 Nov 2002 | K022012 | SYNTHES LOW PROFILE NEURO SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 3 Sep 2002 | K022005 | SYNTHES MIDFACE DISTRACTOR | Synthes (Usa) | JEY Bone Plate |
| 14 Aug 2002 | K021642 | SYNTHES CRANIOFACIAL PLATES | Synthes (Usa) | JEY Bone Plate |
| 23 Apr 2002 | K020505 | SYNTHES TRANSLATING MAXILLARY DISTRACTOR | Synthes (Usa) | JEY Bone Plate |
| 20 Feb 2002 | K020087 | SYNTHES CRANIAL PLATES | Synthes (Usa) | JEY Bone Plate |
| 18 May 2001 | K010690 | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 3 May 2001 | K010499 | SYNTHES (USA) MIDFACE DISTRACTOR | Synthes (Usa) | JEY Bone Plate |
| 25 Apr 2001 | K010527 | SYNTHES (USA) IMF SCREWS | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 17 Jan 2001 | K003393 | MAXILLARY DISTRACTOR | Synthes (Usa) | JEY Bone Plate |
| 16 Nov 2000 | K002935 | SYNTHES 1.5MM TI BROW LIFT SCREW | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 22 Oct 1999 | K990637 | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD | Synthes (Usa) | NEI Temporary Mandibular Condyle Prosthesis |
| 21 Dec 1998 | K983485 | SYNTHES 1.3 MM SELF-DRILLING SCREW | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 18 Aug 1998 | K981890 | SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES | Synthes (Usa) | JEY Bone Plate |
| 29 Jun 1998 | K981362 | SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 25 Jun 1998 | K981275 | SYNTHES (USA) RATCHETING DISTRACTOR | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 17 Apr 1998 | K980199 | SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 3 Mar 1998 | K974555 | SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) | Synthes (Usa) | JEY Bone Plate |
| 24 Feb 1998 | K974554 | SYNTHES RESORBABLE FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 10 Nov 1997 | K973018 | SYNTHES MINI LENGTHENING APPARATUS | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 24 Jun 1997 | K971987 | SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR | Synthes (Usa) | JEY Bone Plate |
| 24 Jun 1997 | K963546 | SMF TITANIUM (TI) ALLOY BONE SCREWS | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 11 Apr 1997 | K964261 | SMF STAINLESS STEEL BONE SCREWS | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 13 Dec 1996 | K964328 | SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE | Synthes (Usa) | JEY Bone Plate |
| 30 Aug 1996 | K962272 | SYNTHES MANDIBLE DISTRACTOR | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 26 Jun 1996 | K961421 | SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 8 Mar 1996 | K953806 | SYNTHES (USA) MIDFACIAL SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 8 Mar 1996 | K954385 | SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Synthes GMBHFDA reg. 3000270450 | Selzach Solothurn, Switzerland | Manufacturer |
| SYNTHES GMBHFDA reg. 3009417901 | Zuchwil Solothurn, Switzerland | Specification developer |
| SYNTHES GMBH / Synthes Produktions GmbHFDA reg. 8030965 | Oberdorf, Baselland Basel-Landschaft, Switzerland | Manufacturer |
Other names on FDA records
Synthes GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9071542). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.