Manufacturer registered with FDA
SYNTHES (USA) Products LLC
West Chester, PA, United States. Lists 11 dental device types with FDA across 2 registered establishments, and holds 7 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 91
- 510(k) clearances
- 72014–2020
- Markets registered in
- 1United States
- Establishments
- 2United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What SYNTHES (USA) Products LLC 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 | CONDYLAR PROSTHESIS OF MANDIBLE W/HEADDepuy Synthes Maxillofacial Portfolio - MR ConditionalePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)MatrixMANDIBLE Fine Pitch ScrewsMatrixMANDIBLE Reconstruction PlatesMatrixMandible Self-Drilling ScrewsMatrixORTHOGNATHIC Plating SystemMatrixWAVE MMF SystemMAXILLARY DISTRACTORplate 32 moreRapid Resorbable Tack SystemSMF Resorbable Mesh and SheetsSYNTHES (USA) [SYNTHES] MINI EXTERNSYNTHES (USA) [SYNTHES] MMFS - 2SYNTHES (USA) CRANIOFACIAL PLATESSYNTHES (USA) MIDFACE DISTRACTORSYNTHES (USA) MIDFACIAL SYSTEMSYNTHES (USA) NEURO PLATE AND SCREWSYNTHES (USA) NEW/STERIAL ORBITAL PSYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEMSYNTHES (USA) RESORBABLE FIXATION SYSTEMSYNTHES (USA) RESORBABLE TACK SYSTEMSYNTHES (USA) SYNTHES MMFS-ADJUSTABSYNTHES 2 MM CRANIOFACIAL LOCKING PLATESSYNTHES 2 MM LOCKING PLATE SYSTEMSYNTHES 2.4 MM UNIVERSAL LOCKING PLSYNTHES CRANIAL PLATESSynthes Craniofacial Plate & ScrewSYNTHES CRANIOFACIAL PLATESSYNTHES DENTOALVEOLAR BONE FIXATION SYSTEMSYNTHES LOW PROFILE NEURO SYSTEMSYNTHES MANDIBULAR MODULAR FIXATIONSYNTHES MATRIXMANDIBLE PLATE AND SCSynthes MatrixMANDIBLE Preformed Reconstruction PlatesSynthes MATRIXMANDIBLE SUBCONDYLARSYNTHES MIDFACE DISTRACTORSynthes Patient Specific PlatesSYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSYNTHES RESORBABLE CONTOURABLE MESHSYNTHES STERILE LOW PROFILE NEURO CSYNTHES TRANSLATING MAXILLARY DISTR1.3 & 1.5MM CONTOURABLE TITANIUM (T | 2007 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | DePuy Synthes Maxillofacial Portfolio - MR ConditionalRAPIDSORB PLUS SCREW SYSTEMSMF STAINLESS STEEL BONE SCREWSSMF TITANIUM (TI) ALLOY BONE SCREWSSYNTHES (USA) 1.3 MM CRANIOFACIAL SSYNTHES (USA) 1/1.22 MM CRANIOFACSYNTHES (USA) EXTERNAL MULTI VECTORSYNTHES (USA) IMF SCREWSSYNTHES 1.3 MM SELF-DRILLING SCREWSYNTHES 1.5MM TI BROW LIFT SCREW 5 moreSYNTHES 1.5MM/2MM ORTHOGNATHIC MASYNTHES 1MM TI. CORTEX, SELF-DRILSynthes Craniofacial Plate & ScrewSYNTHES LOW PROFILE NEURO SYSTEM -SYNTHES TITANIUM MULTI-VECTOR DISTR | 2007 |
| External Mandibular Fixator and/or DistractorMQN · Class 2 | Maxillofacial plates & screws | Maker | CMFD MandibleDePuy Synthes Maxillofacial Portfolio - MR ConditionalMandible External Fixator - MR Conditionalmandibular fiaxtionSYNTHES (USA) (SYNTHES) SINGLE VECTSYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEMSYNTHES (USA) RATCHETING DISTRACTORSYNTHES 2 MM CRANIOFACIAL LOCKING PLATESSYNTHES 9USA) ALVEOLAR RIDGE DISTRACTORSynthes Curvilinear Distraction System 5 moreSYNTHES EXTERNAL MIDFACE DISTRACTORSYNTHES MANDIBLE DISTRACTORSYNTHES MANDIBLE EXTERNAL FIXATORSYNTHES MINI LENGTHENING APPARATUSSYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | 2006 |
| Temporary Mandibular Condyle ProsthesisNEI · Class 2 | — | Maker | DePuy Synthes Maxillofacial Portfolio - MR ConditionalMODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEMSYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEMSYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEA | 2010 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | SYNTHES (USA) ELECTRIC PEN DRIVE SYSynthes 90 Degree Screwdriver | 2007 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | Dental Bone Cutting InstrumentsSynthes 90 Degree Screwdriver | 2009 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | DePuy Synthes Maxillofacial Portfolio - MR ConditionalORTHODONTIC BONE ANCHOR SYSTEMSYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | 2007 |
| Intraoral Wire Lock and LigatureDYX · Class 2 | — | Maker | AND LIGATUREINTRAORALLOCKSYNTHES QUICK LOCK IMF SYSTEM | 2006 |
| Intraosseous Fixation WireDZK · Class 2 | — | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 2020 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | chisel | 1995 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | bone grafting materialchronOS - ß-TCP - LPK | 2009 |
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 (USA) Products LLC as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Sep 2020 | K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | JEY Bone Plate |
| 30 Dec 2019 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | JEY Bone Plate |
| 13 Mar 2019 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | MQN External Mandibular Fixator and/or Distractor |
| 8 May 2017 | K162594 | Craniomaxillofacial Distraction System (CMFD) | MQN External Mandibular Fixator and/or Distractor |
| 23 Jun 2015 | K150796 | Dental Bone Cutting Instruments | DZJ Manual Wire Driver and Bone Drill |
| 28 May 2015 | K143285 | Mandible External Fixator - MR Conditional | MQN External Mandibular Fixator and/or Distractor |
| 17 Oct 2014 | K141165 | MATRIXWAVE MMF SYSTEM | JEY Bone Plate |
Some of these clearances are listed with FDA today by another company: SYNTHES GMBH / Synthes Produktions GmbH (4), DePuy Synthes, Inc. (1).
Also lists devices cleared under other names
SYNTHES (USA) Products LLC 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) (69), SYNTHES GMBH / Synthes Produktions GmbH (5), Zygomatics , Ltd. (1), Norian Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Feb 2013 | K122647 | SYNTHES PATIENT SPECIFIC PLATE | SYNTHES GMBH / Synthes Produktions GmbH | JEY Bone Plate |
| 19 Nov 2012 | K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | SYNTHES GMBH / Synthes Produktions GmbH | JEY Bone Plate |
| 23 Aug 2012 | K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | SYNTHES GMBH / Synthes Produktions GmbH | MQN External Mandibular Fixator and/or Distractor |
| 29 Jun 2012 | K121574 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | SYNTHES GMBH / Synthes Produktions GmbH | JEY Bone Plate |
| 21 Dec 2011 | K113251 | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES | SYNTHES GMBH / Synthes Produktions GmbH | JEY Bone Plate |
| 20 Dec 2010 | K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 16 Dec 2010 | K093299 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Synthes (Usa) | OAT Orthodontic Endosseous Implant |
| 25 Jan 2010 | K093464 | RAPIDSORB PLUS SCREW SYSTEM | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 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 |
| 8 Mar 2007 | K063473 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Synthes (Usa) | OAT Orthodontic Endosseous Implant |
| 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 |
| 4 Mar 2005 | K050204 | SYNTHES RAPID RESORBABLE TACK SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 23 Nov 2004 | K042987 | MODIFICATION TO SYNTHES CRANIAL PLATES | Synthes (Usa) | JEY Bone Plate |
| 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 |
| 29 Oct 2003 | K033065 | SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 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 |
| 27 Jun 2003 | K030605 | RAPID IMF | Zygomatics , Ltd. | DYX Intraoral Wire Lock and Ligature |
| 8 Apr 2003 | K030069 | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 7 Jan 2003 | K022844 | SYNTHES RESORBABLE CONTOURABLE MESH | Synthes (Usa) | JEY Bone Plate |
| 1 Nov 2002 | K022012 | SYNTHES LOW PROFILE NEURO SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 6 Sep 2002 | K021928 | SYNTHES (USA) RESORBABLE FIXATION 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 |
| 10 Jun 2002 | K021850 | SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 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 |
| 27 Feb 2001 | K003786 | SMF RESORBABLE MESHES AND SHEETS | Synthes (Usa) | JEY Bone Plate |
| 17 Jan 2001 | K003393 | MAXILLARY DISTRACTOR | Synthes (Usa) | JEY Bone Plate |
| 9 Jan 2001 | K000560 | SYNTHES (USA) RESORBABLE TACK SYSTEM | 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 |
| 23 Jun 1999 | K991004 | SYNTHES QUICK LOCK IMF SYSTEM | Synthes (Usa) | DYX Intraoral Wire Lock and Ligature |
| 12 Feb 1999 | K983104 | NORIAN PERIODONTAL/DENTAL CEMENT (PDC) | Norian Corp. | LYC Synthetic Bone Grafting Material |
| 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 |
| 22 Jun 1998 | K981075 | SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET | 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 |
| 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 | K954385 | SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 8 Mar 1996 | K953806 | SYNTHES (USA) MIDFACIAL SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 19 Jun 1984 | K840955 | CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD | Synthes (Usa) | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DePuy Synthes SalesFDA reg. 3034676720 | Bridgewater, MA, United States | Repacker / relabeler |
| Synthes (USA) Products LLCFDA reg. 3008812560 | West Chester, PA, United States | Complaint file establishment, Specification developer |
Other names on FDA records
DePuy Synthes Sales
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2520274). 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.