Maxillofacial plates & screws: manufacturers and brands
78 companies make or specify maxillofacial plates among the 92 that list one with FDA, under 2,725 brand and model names. FDA has issued 435 510(k) clearances in this category, 27 of them in the last five years.
510(k) clearances per year, 1976–2026
Maxillofacial plate manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | MEMFIX · Neodent Graft Screw | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | SAVE GBR | 37 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | i-Gen | 30 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | Ossbuilder · SMARTbuilder system · SMARTbuilder System(SB1) · Bone Screw · +3 | 68 | 2026 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| BioHorizons Implant Systems, Inc. | United States | Maker | ACE BONE SCREW TACKING KIT · The Autotac System · The Autotac System Titanium Tack · MINIBONEPLATE SYSTEM | 41 | 2026 |
| Stryker | United States | Maker | add name · Burr Hole covers · Custom Mandible Recon Plate · Delta DualStart · +30 | 33 | 2024 |
| Young Innovations Inc | United States | Maker | Salvin Dental Fixation Screw · Salvin Dental Specialties Bone Tack System · Salvin Tenting Screws · Salvin Titanium Mesh | 23 | 2025 |
| X-NAV Technologies, LLC. | United States | Maker | EDX Bone Screw · EDX Tracker Arm · X-Guide Surgical Navigation System | 6 | 2026 |
| Neobiotech Co., Ltd. | South Korea | Maker | Neo GBR System | 17 | 2024 |
| Hager& Meisinger GmbH | Germany | Maker | Master Pin Control (Basic) · Master-Pin X · Meisinger Dental Bone Screw · Meisinger Tacs and Pins · +3 | 14 | 2025 |
| Materialise NV | Belgium | Maker | ProPlan CMF Guides · SurgiCase CMF Guides · TruMatch CMF Ti 3D-Printed Implants · TruMatch CMF Ti 3D-Printed Plates · +2 | 5 | 2026 |
| MedCAD | United States | Maker | AccuPlate · AccuPlate 3DTi Patient-Specific Plating System · AccuPlate Patient-Specific Plate | 4 | 2023 |
| Meticuly Co., Ltd. | Thailand | Maker | METICULY Patient-specific titanium maxillofacial mesh implant | 2 | 2026 |
| Osteomed, LLC | United States | Maker | — | 26 | 2022 |
| Beijing Naton Technology Group Co. Ltd. | China | Maker | Inion CPS 1.5/2/2.5 Bioabsorbable Fixation System · Inion CPS Baby 1.5 Bioabsorbable Fixation System · Inion CPS Baby Biodegradable Fixation System · Inion CPS Biodegradable Fixation System · +3 | 10 | 2025 |
| Neoss AB | Sweden | Maker | — | 10 | 2022 |
| Jeil Medical Corporation | South Korea | Maker | Bone Fixation Screw Kit · GBR System · JEIL BONE FIXATION SYSTEM · Leforte MMF System · +30 | 9 | 2026 |
| Biomaterials Korea, Inc. | South Korea | Maker | ACR | 5 | 2023 |
| Microware Precision Co., Ltd. | Taiwan | Maker | Biomet Microfixation OmniMax MMF System · LORENZ 1MM, 1.5MM, 2MM SYSTEM · Tandry CMF Plate System | 2 | 2022 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Guided Bone Regeneration System | 1 | 2026 |
| Southern Medical (Pty) Ltd | South Africa | Maker | Southern Maxillofacial (MF) system | 1 | 2025 |
| Bioplate, Inc. | United States | Maker | Bioplate Rigid Fixation Bone · Modified Sterile Plate & Screw kit configurations for use with Bioplate Titanium Fixation System · Plating System · Rigid Fixation Bone Plating System · +6 | 17 | 2008 |
| Zimmer Inc | United States | Maker | AND PREBENT · BIOMET MICROFIXATION · Biomet Microfixation OmniMax MMF System · DISTRACTOR SYSTEM · +33 | 14 | 2001 |
| Medtronic, Inc. | United States | Maker | ARCHITEX · MACROPORE FX, PS, NS, LP · MACROPORE PROTECTIVE SHEET · MACROPORE-PX PEDIATRIC SYSTEM · +3 | 11 | 2014 |
| Impladent , Ltd. | United States | Maker | TriStar Bone Graft Fixation System | 10 | 2014 |
| Unicare Biomedical, Inc. | United States | Maker | CYTOFLEX MESH | 9 | 2015 |
| Medicon EG | Germany | Maker | — | 9 | 2005 |
| Biomet Microfixation | United States | Maker | Bi Phase · CMF System · Fracture/Reconstruction Plating · Mandibular Fracture/Reconstruction Devices · +21 | 8 | 2021 |
| SYNTHES (USA) Products LLC | United States | Maker | CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD · Depuy Synthes Maxillofacial Portfolio - MR Conditional · ePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) · MatrixMANDIBLE Fine Pitch Screws · +65 | 7 | 2020 |
| Medartis AG | Switzerland | Maker | MODUS 2.5 Mandibular Reconstruction System · MODUS Sagittal Split Plate and Slider · MODUS Titanium Ostheosynthesis System · MODUS TriLock 2/2.3/2.5 · +1 | 6 | 2007 |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | Maker | MatrixORTHOGNATHIC Plating System · plate · PLATE, BONE · SYNTHES (USA) [SYNTHES] MINI EXTERN · +16 | 5 | 2013 |
| Osteogenics Biomedical, Inc. | United States | Maker | Osteo-Mesh TM-300 Titanium Mesh · RPM Reinforced PTFE Mesh · Pro-fix Bone Fixation Screws · Pro-fix Membrane Fixation Screws · +2 | 5 | 2021 |
| OSTEONIC Co., Ltd. | South Korea | Maker | OPTIMUS CMF System | 3 | 2021 |
| Storz AM Mark GmbH | Germany | Maker | micro-screw · Titanium screw | 2 | 2008 |
| Surgident Co., Ltd. | South Korea | Maker | GBR System SD-Screw, Bone Tac · GBR System Titanium Mesh | 2 | 2019 |
| Mci Medical Concept Innovation, Inc. | United States | Maker | A011.1000 STRAIGHT MICRO PLATE 4H · A011.1002 STRAIGHT MICRO PLATE 6H · A011.1004 STRAIGHT MICRO PLATE 8H · A011.1006 STRAIGHT MICRO PLATE 10H · +1,061 | 1 | 2019 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | — | 1 | 2007 |
| NEOORTHO Produtos Ortopedicos S/A | Brazil | Maker | CranioMaxillofacial Fixation (CMF) System - CMF Visionare · Mini and Micro Fragments Reconstruction System - NEOFACE · Neoortho · Visionare | 1 | 2010 |
| Dsm Biomedical | United States | Maker | — | 1 | 2020 |
| Visionare LLC | United States | Maker | VISIONARE | 1 | 2018 |
| ReOss GmbH | Germany | Maker | Yxoss | 1 | 2020 |
| Vme Acquisition Corp. | United States | Maker | — | 1 | 1998 |
| Precision One Medical | United States | Maker | THE AUTOTAC SYSTEM TITANIUM TACK | — | — |
| MC Bio s.r.l. | Italy | Maker | MC Bio Supertack tack 3mm · MC Bio Supertack tack 4mm · MC Bio Supertack tack 5mm | — | — |
| Aesculap AG | Germany | Maker | — | — | — |
| Unique Instruments Inc. | United States | Maker | ACE Mini Bone Plate System · RESORBABLE FIXATION SYSTEM · SYNTHES CRANIOFACIAL PLATES · RAPIDSORB PLUS SCREW SYSTEM · +1 | — | — |
| Micro Precision Swiss, LLC | United States | Maker | TiMesh System for Reconstructive Surgery and Rigid Fixation of the bones of the face and skull · TiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System · TiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System for Rigid Fixation of the Bones of the Face and Sk | — | — |
| LX Precision Shanghai Co. Ltd. | China | Maker | Biomet Microfixation OmniMax MMF System · CMF System · Neuro System · TraumaOne System · +18 | — | — |
| Jabil Inc. | United States | Maker | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) · DePuy Synthes Maxillofacial Portfolio - MR Conditional · Plate · SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR · +10 | — | — |
| Tecomet | United States | Maker | TiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw system · Cranialplasty | — | — |
| DePuy Synthes, Inc. | United States | Maker | MAXILLARY DISTRACTOR · SYNTHES (USA) [SYNTHES] MINI EXTERN · SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM · SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY · +3 | — | — |
| Frueh Verpackungstechnik AG | Switzerland | Maker | Craniofacial Plate and Screw System · Neuro Plate and Screw System | — | — |
| Complexus Medical | United States | Maker | Set Screw Dog Point M4x5, Blue Device · 180mm Carbon Rod, Blue Device · 25mm Qc Dual Rail Distractor | — | — |
| Kontour (Xi'an) Medical Technology Co., Ltd. | China | Maker | BIOMESH · Bioplate Rigid Fixation System · Modification to Bioplate Rigid Fixation System · Modified Screw Design · +2 | — | — |
| ARCH Medical Solutions - Escondido LLC | United States | Maker | PLATE, BONE | — | — |
| Celestica de Monterrey S.A. de C.V. | Mexico | Maker | JGRKNT 1MM MINI STEP DRILL · 1mm JuggerKnot Mini 2-0 w/ Tapered Needles · 1mm JuggerKnot Mini 2-0 w/ Tapered Needles Multi Pack · 1mm JuggerKnot Mini 3-0 w/ Tapered Needles · +1 | — | — |
| Quality Aspirators | United States | Maker | Salvin Dental Fixation Screw | — | — |
| Sphinx Tools Ltd | Switzerland | Maker | CMF Medicon Surgical Inc | — | — |
| Eptam West LLC | United States | Maker | JEY - PLATE, BONE · DZL - SCREW, FIXATION, INTRAOSSEOUS | — | — |
| Quintus, Inc. | United States | Maker | CARBON FIBER ROD · 4MM CARBON FIBER ROD · 3MM CARBON FIBER ROD | — | — |
| 3D Medical Manufacturing, inc. DBA Tecomet | United States | Maker | SYNTHES (USA) 1/1.22 MM CRANIOFACIAL SCREWS · SYNTHES 1MM TI. CORTEX SELF-DRILLING SCREWS (CARNIOFACIAL) | — | — |
| Matrix Surgical Holdings, LLC. dba Matrix Surgical USA | United States | Maker | OMNIPORE DUROMAX Surgical Implants · OMNIPORE DUROMAX ZB Orbital Implant | — | — |
| General Machine, Inc. | United States | Maker | Device-01 | — | — |
| Acumed LLC | United States | Maker | — | — | — |
| Arctic Biomaterials Oy | Finland | Maker | — | — | — |
| Autocam Medical | United States | Maker | — | — | — |
| Avalign Instruments & Implants | United States | Maker | — | — | — |
| BEMOTEC GmbH | Germany | Maker | — | — | — |
| DIENER & RAPP GmbH & Co. KG | Germany | Maker | — | — | — |
| DOT GmbH | Germany | Maker | — | — | — |
| Eurofins inpac Medizintechnik GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| KLS Martin Manufacturing, LLC | United States | Maker | — | — | — |
| Laser Integration Laser Applikation GmbH | Germany | Maker | — | — | — |
| Part Precision Sweden AB | Sweden | Maker | — | — | — |
| Wesley Coe (Cambridge) Ltd. | United Kingdom | Maker | — | — | — |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | X-guide | 94 | 2026 |
| Suncoast Dental Corp. | United States | Repacker / relabeler | Tatum Surgical | 2 | 1981 |
| Aesculap, Inc. | United States | Lister | — | 2 | 2006 |
| Sotera Health LLC | United States | Contract manufacturer | ACCESS PORT W / STABILITY 3/5 X 70MM · Bioplate Sterile Kits · Macropore FX, PS, NS, LP · Macropore MX Mandibular Fixation System · +79 | — | — |
| Swann Morton Limited | United Kingdom | Contract sterilizer | Membrane Screws and Membrane Tacks · SCREW, FIXATION, INTAOSSEOUS | — | — |
| STERIS Corporation | United States | Contract sterilizer | Synthes8894 (DK) - POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RAPID RESORBABLE FIXATION SYS · Synthes8894 (DK) -POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RAPID RESORBABLE FIXATION SYS · UnicareBiomed3455 (NT) Cytoflex mesh | — | — |
| Exel Inc. dba DHL Supply Chain (USA) | United States | Repacker / relabeler | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) · MATRIXWAVE MMF SYSTEM · MAXILLARY DISTRACTOR · Synthes (U.S.A) Resorbable Fixation System · +50 | — | — |
| BBF Sterilisationsservice GmbH | Germany | Contract manufacturer | KLS Martin Resorb-X G (Oral Max) · KLS Martin Rigid Fixation - Sterile · PLATE, BONE · SonicWeld RX (Resorb-X) · +3 | — | — |
| Curitiba Esterilizacao De Materiais Medicos LTDA | Brazil | Contract sterilizer | Neodent Graft Screw | — | — |
| HANSAMED LIMITED dba CITAGENIX | Canada | Foreign exporter | Citagenix | — | — |
| Steritec Services LLC | United States | Contract sterilizer | dental bone plate | — | — |
| Centerpiece Holdings LLC | United States | Contract sterilizer | BIOMET SPORTS MEDICINE | — | — |
| ZimmerBiomet Americas DFE | United States | Foreign exporter | JUGGERKNOT MINI SOFT ANCHOR | — | — |
| GAMMATOM Srl | Italy | Contract sterilizer | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where maxillofacial plates are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Bone PlateJEY | 2 | 872.4760 | 56 | 294 |
| Intraosseous Fixation ScrewDZL | 2 | 872.4880 | 46 | 81 |
| External Mandibular Fixator and/or DistractorMQN | 2 | 872.4760 | 15 | 60 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Aug 2026 | K254286 | Guided Bone Regeneration System | DentalMaster (Xiamen) Medical Technology Co., Ltd. | DZL Intraosseous Fixation Screw |
| 17 Aug 2026 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | KLS Martin SE & Co. KG | JEY Bone Plate |
| 25 Jul 2026 | K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | JEY Bone Plate |
| 2 Apr 2026 | K252246 | Leforte MMF System | Jeil Medical Corporation | JEY Bone Plate |
| 19 Dec 2025 | K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) Ltd | JEY Bone Plate |
| 7 Nov 2025 | K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Beijing Naton Technology Group Co. Ltd. | JEY Bone Plate |
| 29 Sep 2025 | K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | DZL Intraosseous Fixation Screw |
| 13 Aug 2025 | K251569 | Bone Screw | Osstem Implant Co., Ltd. | DZL Intraosseous Fixation Screw |
| 27 Jun 2025 | K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | DZL Intraosseous Fixation Screw |
| 3 Jan 2025 | K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | DZL Intraosseous Fixation Screw |
| 17 Oct 2024 | K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | DZL Intraosseous Fixation Screw |
| 17 Sep 2024 | K233721 | KLS Martin Drill-Free MMF Screw | KLS Martin SE & Co. KG | DZL Intraosseous Fixation Screw |
| 16 Aug 2024 | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS Martin SE & Co. KG | JEY Bone Plate |
| 12 Jul 2024 | K240651 | MRI Universal | Stryker | JEY Bone Plate |
| 11 Jul 2024 | K233874 | tmCMF Solution | Techmah Cmf | JEY Bone Plate |
| 30 Apr 2024 | K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | JEY Bone Plate |
| 13 Jan 2024 | K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | JEY Bone Plate |
| 26 Sep 2023 | K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | MedCAD | JEY Bone Plate |
| 24 Aug 2023 | K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker | DZL Intraosseous Fixation Screw |
| 5 Aug 2023 | K230733 | Stryker Resorbable Fixation System | Stryker | JEY Bone Plate |
| 23 Mar 2023 | K222367 | SAVE GBR | Dentis Co., Ltd. | DZL Intraosseous Fixation Screw |
| 9 Dec 2022 | K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | JEY Bone Plate |
| 10 Nov 2022 | K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | JEY Bone Plate |
| 9 Nov 2022 | K221855 | Universal CMF System | Stryker | JEY Bone Plate |
| 11 Aug 2022 | K220050 | KLS Martin IPS Distraction | KLS Martin SE & Co. KG | MQN External Mandibular Fixator and/or Distractor |
| 18 Jul 2022 | K210731 | KLS Martin Individual Patient Solutions | KLS Martin SE & Co. KG | JEY Bone Plate |
| 4 Feb 2022 | K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | JEY Bone Plate |
| 8 Oct 2021 | K201210 | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH | DZL Intraosseous Fixation Screw |
| 5 Aug 2021 | K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | JEY Bone Plate |
| 14 Jul 2021 | K202918 | OsteoSync Ti Dental Mesh | Sites Medical, LLC | JEY Bone Plate |
| 19 May 2021 | K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | JEY Bone Plate |
| 12 Feb 2021 | K193280 | MedCAD® AccuPlate® Patient-Specific Plate | MedCAD | JEY Bone Plate |
| 5 Oct 2020 | K201561 | Membrane Screws and Membrane Tacks | Neoss AB | DZL Intraosseous Fixation Screw |
| 10 Sep 2020 | K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | SYNTHES (USA) Products LLC | JEY Bone Plate |
| 29 Jul 2020 | K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | JEY Bone Plate |
| 17 Jun 2020 | K192747 | Yxoss CBR® | ReOss GmbH | JEY Bone Plate |
| 22 Apr 2020 | K191997 | FAICO CMF System | Faico Medical, LLC | JEY Bone Plate |
| 26 Mar 2020 | K193143 | Stryker Facial iD Plating System | Stryker | JEY Bone Plate |
| 26 Mar 2020 | K193136 | Stryker Customized Mandible Recon Plate Kit | Stryker | JEY Bone Plate |
| 30 Dec 2019 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | SYNTHES (USA) Products LLC | JEY Bone Plate |