| METICULY Patient-specific CMF solution (K253206) | Meticuly Co., Ltd. | 2026-07-25 |
| Leforte MMF System (K252246) | Jeil Medical Corporation | 2026-04-02 |
| Southern Craniomaxillofacial (CMF) System (K253373) | Southern Medical (Pty) , Ltd. | 2025-12-19 |
| Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (K251441) | Inion OY | 2025-11-07 |
| KLS Martin Oral-Max Implants MR Conditional (bundled) (K241314) | KLS-Martin L.P. | 2024-08-16 |
| MRI Universal (K240651) | Stryker Leibinger GmbH & Co KG | 2024-07-12 |
| tmCMF Solution (K233874) | Techmah Cmf | 2024-07-11 |
| METICULY Patient-specific titanium maxillofacial mesh implant (K232889) | Meticuly Co., Ltd. | 2024-04-30 |
| Stryker Facial iD System (K232350) | Stryker Craniomaxillofacial | 2024-01-13 |
| MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (K230398) | Medcad | 2023-09-26 |
| Stryker Resorbable Fixation System (K230733) | Stryker Leibinger GmbH & Co KG | 2023-08-05 |
| Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate (K222650) | Stryker Craniomaxillofacial (Cmf) | 2022-12-09 |
| Tandry CMF Plate System (K220360) | Microware Precision Co., Ltd. | 2022-11-10 |
| Universal CMF System (K221855) | Stryker Leibinger GmbH & Co KG | 2022-11-09 |
| KLS Martin Individual Patient Solutions (K210731) | KLS-Martin L.P. | 2022-07-18 |
| Stryker Resorbable Fixation System (K213777) | Stryker Leibinger Micro Implants | 2022-02-04 |
| Biomet Microfixation OmniMax MMF System (K202969) | Biomet Microfixation | 2021-08-05 |
| OsteoSync™ Ti Dental Mesh (K202918) | Sites Medical, LLC | 2021-07-14 |
| TECHFIT Patient-Specific Maxillofacial System (K203282) | Industrias Medicas Sampedro S.A.S | 2021-05-19 |
| MedCAD® AccuPlate® Patient-Specific Plate (K193280) | Medcad | 2021-02-12 |
| DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) (K201944) | Synthes (USA) Products, LLC | 2020-09-10 |
| BoniPlus Dental G-Mesh System (K182759) | Montjade Engineering Co., Ltd. | 2020-07-29 |
| Yxoss CBR® (K192747) | Reoss GmbH | 2020-06-17 |
| FAICO CMF System (K191997) | Faico Medical, LLC | 2020-04-22 |
| Stryker Facial iD Plating System (K193143) | Stryker | 2020-03-26 |
| Stryker Customized Mandible Recon Plate Kit (K193136) | Stryker | 2020-03-26 |
| Depuy Synthes Maxillofacial Portfolio - MR Conditional (K192655) | Synthes (USA) Products, LLC | 2019-12-30 |
| MCI - CMF System (K182758) | Mci Medical Concept Innovation, Inc. | 2019-12-05 |
| KLS Martin Individual Patient Solutions (K191028) | KLS-Martin L.P. | 2019-11-22 |
| Stryker Surgeon iD Mandible Recon Plate (K190696) | Stryker | 2019-06-28 |
| Delphos Implants Rigid Fixation System (K182609) | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 2019-03-29 |
| Stryker Facial iD Plating System (K182305) | Stryker | 2019-01-07 |
| CranioMaxillofacial Fixation (CMF) System - CMF Visionare (K180204) | Visionare, LLC | 2018-12-28 |
| OmniPore DUROMAX Surgical Implants (K180249) | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2018-10-11 |
| KLS Martin Individual Patient Solutions (K180962) | KLS-Martin L.P. | 2018-08-13 |
| TruMatch CMF Titanium 3D Printed Implant (K173039) | Materialise NV | 2018-07-10 |
| GBR system (K170697) | Surgident | 2018-05-24 |
| OssBuilder System (K172354) | Osstem Implant Co., Ltd. | 2018-03-26 |
| KLS Martin L1 MMF System (K173320) | KLS Martin L.P. | 2018-02-23 |
| KLS Martin Individual Patient Solutions (K163579) | KLS Martin L.P. | 2017-11-21 |
| Stryker Universal Mesh (K170773) | Stryker | 2017-11-08 |
| Stryker Upper-Face AXS screws and Mid-Face AXS screws (K172572) | Stryker | 2017-10-31 |
| TruMatch CMF Titanium 3D Printed Implant System (K170272) | Materialise NV | 2017-08-08 |
| MP LeFort I Plates (K171364) | Stryker | 2017-07-24 |
| OPTIMUS CMF SYSTEM (K160363) | Osteonic Co., Ltd. | 2016-10-20 |
| Biomet Microfixation OmniMax MMF System (K152326) | Biomet Microfixation | 2015-12-10 |
| LeForte System II (K150965) | Jeil Medical Corporation | 2015-09-17 |
| GBR System (K143730) | Jeil Medical Corporation | 2015-06-10 |
| Stryker MEDPOR TITAN 3D Orbital Floor Implant (K142568) | Stryker | 2015-05-05 |
| Argulated Locking Plates (K143338) | Osteomed LP | 2015-04-01 |
| Biomet Microfixation OmniMax MMF System (K143336) | Biomet Microfixation | 2015-04-01 |
| OPTIMUS CMF SYSTEM (K140037) | Osteonic Co., Ltd. | 2015-01-20 |
| OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM (K140978) | Osteomed | 2014-12-18 |
| TRISTAR BONE GRAFT FIXATION SYSTEM (K141764) | Impladent , Ltd. | 2014-12-18 |
| MATRIXWAVE MMF SYSTEM (K141165) | Synthes (USA) Products, LLC | 2014-10-17 |
| STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM (K133461) | Stryker | 2014-08-01 |
| RXG DISTRACTION SYSTEM (K133304) | KLS-Martin L.P. | 2014-05-15 |
| LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM (K121235) | Stryker | 2014-01-09 |
| STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT (K132519) | Stryker | 2013-12-06 |
| FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING (K132600) | Biomet Microfixation | 2013-10-02 |
| I-GEN (K131289) | Megagen Implant Co., Ltd. | 2013-09-25 |
| SMARTBUILDER SYSTEM (SB1) (K130840) | Osstem Implant Co., Ltd. | 2013-09-18 |
| PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING (K131674) | Biomet Microfixation | 2013-08-08 |
| STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM (K123786) | Stryker | 2013-04-09 |
| SYNTHES PATIENT SPECIFIC PLATE (K122647) | Synthes, Inc. | 2013-02-28 |
| INION CPS ORBITAL PLATES (K122890) | Inion OY | 2013-01-29 |
| SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM (K113567) | Synthes, Inc. | 2012-11-19 |
| STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM (K122313) | Stryker | 2012-10-31 |
| SMARTBUILDER SYSTEM (K120951) | Osstem Implant Co., Ltd. | 2012-10-03 |
| BIOMET MICROFIXATION FACIAL PLATING SYSTEM (K121589) | Biomet Microfixation | 2012-09-21 |
| BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM (K113512) | Biomet Microfixation | 2012-06-29 |
| SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM (K121574) | Synthes, Inc. | 2012-06-29 |
| ARTISAN SPACE MAINTENANCE SYSTEM (K120271) | Medtronic Sofamor Danek USA, Inc. | 2012-05-30 |
| LEFORTE SYSTEM BONE PLATE & SCREW (K112457) | Arkin Consulting Group | 2012-05-18 |
| RESORB X-G (K112064) | KLS-Martin L.P. | 2012-03-23 |
| NEO TITANIUM MESH, CTI-MEM (K111761) | Neobiotech Co., Ltd. | 2012-01-10 |
| SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES (K113251) | Synthes, Inc. | 2011-12-21 |
| BONE PLATE; BONE SCREW (K110926) | Biomaterials Korea, Inc. | 2011-12-08 |
| ARCHITEX SPACE MAINTENANCE SYSTEM (K110259) | Medtronic Sofamor Danek USA, Inc. | 2011-04-13 |
| SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE (K103136) | Materialise NV | 2011-03-18 |
| LEFORTE NEURO SYSTEM BONE PLATE (K103778) | Jeil Medical Corporation | 2011-01-26 |
| MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE (K102641) | Neoortho Produtos Ortopedicos S/A | 2010-12-20 |
| SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM (K102656) | Synthes (Usa) | 2010-12-20 |
| SUSTAIN SPACE MAINTENANCE SYSTEM (K100779) | Medtronic Sofamor Danek USA, Inc. | 2010-12-13 |
| MEDPOR FIXATION SYSTEM (K091807) | Porex Surgical, Inc. | 2010-06-28 |
| FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS (K091812) | Frontier Devices, Inc. | 2010-05-07 |
| THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM (K092743) | Stryker Craniomaxillofacial | 2010-01-15 |
| SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES (K091233) | Synthes (Usa) | 2009-12-11 |
| LEFORTE SYSTEM BONE PLATE (K091679) | Jeil Medical Corporation | 2009-10-02 |
| SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES (K091144) | Synthes (Usa) | 2009-08-25 |
| SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM (K083388) | Synthes (Usa) | 2009-03-12 |
| SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM (K082335) | Synthes (Usa) | 2008-11-10 |
| MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM (K073307) | Bio-Technology USA, Inc. | 2008-10-29 |
| MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM (K082757) | Bioplate, Inc. | 2008-10-01 |
| SONICWELD RX (RESORB-X) (K080862) | KLS-Martin L.P. | 2008-07-21 |
| OSTEOMED MODULAR LOCKING FIXATION SYSTEM (K080694) | Osteomed LP | 2008-05-15 |
| FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) (K081067) | Biomet Microfixation, Inc. | 2008-05-09 |
| SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM (K080331) | Synthes (Usa) | 2008-04-30 |
| ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES (K072528) | Prosurg, Inc. | 2007-12-28 |
| SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM (K072463) | Satyrne Medical | 2007-11-29 |