Plate, Bone
FDA product code JEY · Class II (moderate risk) · 21 CFR 872.4760 · Dental
294510(k) clearances
0PMA approvals
110recalls
Implantimplanted device
Manufacturers
- Synthes (Usa) 38
- KLS-Martin L.P. 19
- Bioplate, Inc. 16
- Walter Lorenz Surgical, Inc. 15
- Stryker Corporation 13
- Biomet Microfixation, Inc. 8
- Inion , Ltd. 8
- Bionx Implants, Inc. 7
- Medicon EG 7
- Osteomed LP 7
- Biomedics 6
- Jeil Medical Corporation 6
- Howmedica Corp. 6
- Howmedica Leibinger, Inc. 5
- Stryker Instruments 5
- Implant Innovations, Inc. 4
- Biomet, Inc. 4
- Stryker Leibinger GmbH & Co. KG 4
- Patton, Boggs & Blow 4
- Medartis AG 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | KLS-Martin L.P. | 08/17/2026SE |
| K253206 | METICULY Patient-specific CMF solutionJEY · Traditional | Meticuly Co., Ltd. | 07/25/2026SE |
| K252246 | Leforte MMF SystemJEY · Traditional | Jeil Medical Corporation | 04/02/2026SE |
| K253373 | Southern Craniomaxillofacial (CMF) SystemJEY · Traditional | Southern Medical (Pty) , Ltd. | 12/19/2025SE |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional | Inion OY | 11/07/2025SE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional | KLS-Martin L.P. | 08/16/2024SE |
| K240651 | MRI UniversalJEY · Traditional | Stryker Leibinger GmbH & Co KG | 07/12/2024SE |
| K233874 | tmCMF SolutionJEY · Traditional | Techmah Cmf | 07/11/2024SE |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implantJEY · Traditional | Meticuly Co., Ltd. | 04/30/2024SE |
| K232350 | Stryker Facial iD SystemJEY · Traditional | Stryker Craniomaxillofacial | 01/13/2024SE |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY · Traditional | Medcad | 09/26/2023SE |
| K230733 | Stryker Resorbable Fixation SystemJEY · Traditional | Stryker Leibinger GmbH & Co KG | 08/05/2023SE |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateJEY · Traditional | Stryker Craniomaxillofacial (Cmf) | 12/09/2022SE |
| K220360 | Tandry CMF Plate SystemJEY · Traditional | Microware Precision Co., Ltd. | 11/10/2022SE |
| K221855 | Universal CMF SystemJEY · Traditional | Stryker Leibinger GmbH & Co KG | 11/09/2022SE |
| K210731 | KLS Martin Individual Patient SolutionsJEY · Traditional | KLS-Martin L.P. | 07/18/2022SE |
| K213777 | Stryker Resorbable Fixation SystemJEY · Special | Stryker Leibinger Micro Implants | 02/04/2022SE |
| K202969 | Biomet Microfixation OmniMax MMF SystemJEY · Traditional | Biomet Microfixation | 08/05/2021SE |
| K202918 | OsteoSync Ti Dental MeshJEY · Traditional | Sites Medical, LLC | 07/14/2021SE |
| K203282 | TECHFIT Patient-Specific Maxillofacial SystemJEY · Traditional | Industrias Medicas Sampedro S.A.S | 05/19/2021SE |
| K193280 | MedCAD® AccuPlate® Patient-Specific PlateJEY · Traditional | Medcad | 02/12/2021SE |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)JEY · Special | Synthes (USA) Products, LLC | 09/10/2020SE |
| K182759 | BoniPlus Dental G-Mesh SystemJEY · Traditional | Montjade Engineering Co., Ltd. | 07/29/2020SE |
| K192747 | Yxoss CBR®JEY · Traditional | Reoss GmbH | 06/17/2020SE |
| K191997 | FAICO CMF SystemJEY · Traditional | Faico Medical, LLC | 04/22/2020SE |
| K193143 | Stryker Facial iD Plating SystemJEY · Special | Stryker | 03/26/2020SE |
| K193136 | Stryker Customized Mandible Recon Plate KitJEY · Special | Stryker | 03/26/2020SE |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR ConditionalJEY · Traditional | Synthes (USA) Products, LLC | 12/30/2019SE |
| K182758 | MCI - CMF SystemJEY · Traditional | Mci Medical Concept Innovation, Inc. | 12/05/2019SE |
| K191028 | KLS Martin Individual Patient SolutionsJEY · Traditional | KLS-Martin L.P. | 11/22/2019SE |
| K190696 | Stryker Surgeon iD Mandible Recon PlateJEY · Special | Stryker | 06/28/2019SE |
| K182609 | Delphos Implants Rigid Fixation SystemJEY · Traditional | Delphos Implants - Ind.Com. Importacao E… | 03/29/2019SE |
| K182305 | Stryker Facial iD Plating SystemJEY · Traditional | Stryker | 01/07/2019SE |
| K180204 | CranioMaxillofacial Fixation (CMF) System - CMF VisionareJEY · Traditional | Visionare, LLC | 12/28/2018SE |
| K180249 | OmniPore DUROMAX Surgical ImplantsJEY · Traditional | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 10/11/2018SE |
| K180962 | KLS Martin Individual Patient SolutionsJEY · Traditional | KLS-Martin L.P. | 08/13/2018SE |
| K173039 | TruMatch CMF Titanium 3D Printed ImplantJEY · Traditional | Materialise NV | 07/10/2018SE |
| K170697 | GBR systemJEY · Traditional | Surgident | 05/24/2018SE |
| K172354 | OssBuilder SystemJEY · Traditional | Osstem Implant Co., Ltd. | 03/26/2018SE |
| K173320 | KLS Martin L1 MMF SystemJEY · Traditional | KLS Martin L.P. | 02/23/2018SE |
| K163579 | KLS Martin Individual Patient SolutionsJEY · Traditional | KLS Martin L.P. | 11/21/2017SE |
| K170773 | Stryker Universal MeshJEY · Traditional | Stryker | 11/08/2017SE |
| K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screwsJEY · Special | Stryker | 10/31/2017SE |
| K170272 | TruMatch CMF Titanium 3D Printed Implant SystemJEY · Traditional | Materialise NV | 08/08/2017SE |
| K171364 | MP LeFort I PlatesJEY · Special | Stryker | 07/24/2017SE |
| K160363 | Optimus CMF SystemJEY · Special | Osteonic Co., Ltd. | 10/20/2016SE |
| K152326 | Biomet Microfixation OmniMax MMF SystemJEY · Traditional | Biomet Microfixation | 12/10/2015SE |
| K150965 | LeForte System IIJEY · Traditional | Jeil Medical Corporation | 09/17/2015SE |
| K143730 | GBR SystemJEY · Traditional | Jeil Medical Corporation | 06/10/2015SE |
| K142568 | Stryker MEDPOR TITAN 3D Orbital Floor ImplantJEY · Traditional | Stryker | 05/05/2015SE |
| K143338 | Argulated Locking PlatesJEY · Special | Osteomed LP | 04/01/2015SE |
| K143336 | Biomet Microfixation OmniMax MMF SystemJEY · Traditional | Biomet Microfixation | 04/01/2015SE |
| K140037 | Optimus CMF SystemJEY · Traditional | Osteonic Co., Ltd. | 01/20/2015SE |
| K141764 | Tristar Bone Graft Fixation SystemJEY · Traditional | Impladent , Ltd. | 12/18/2014SE |
| K140978 | Osteomed Low Profile Orbital Floor Plate SystemJEY · Traditional | Osteomed | 12/18/2014SE |
| K141165 | Matrixwave MMF SystemJEY · Traditional | Synthes (USA) Products, LLC | 10/17/2014SE |
| K133461 | Stryker Universal Orbital Floor SystemJEY · Traditional | Stryker | 08/01/2014SE |
| K133304 | RXG Distraction SystemJEY · Traditional | KLS-Martin L.P. | 05/15/2014SE |
| K121235 | Leibinger Advance Internal Midface Distraction SystemJEY · Traditional | Stryker | 01/09/2014SE |
| K132519 | Stryker Customized Mandible Recon Plate KitJEY · Traditional | Stryker | 12/06/2013SE |
| K132600 | Facial Prebent Plating with Virtual Surgical PlanningJEY · Special | Biomet Microfixation | 10/02/2013SE |
| K131289 | I-GenJEY · Traditional | Megagen Implant Co., Ltd. | 09/25/2013SE |
| K130840 | Smartbuilder System (SB1)JEY · Traditional | Osstem Implant Co., Ltd. | 09/18/2013SE |
| K131674 | Prebent Plating with Virtual Surgical PlanningJEY · Special | Biomet Microfixation | 08/08/2013SE |
| K123786 | Stryker Universal Orbital Floor SystemJEY · Traditional | Stryker | 04/09/2013SE |
| K122647 | Synthes Patient Specific PlateJEY · Traditional | Synthes, Inc. | 02/28/2013SE |
| K122890 | Inion CPS Orbital PlatesJEY · Traditional | Inion OY | 01/29/2013SE |
| K113567 | Synthes Matrixmadible Plate and Screw SystemJEY · Traditional | Synthes, Inc. | 11/19/2012SE |
| K122313 | Stryker Universal Smartlock Hybrid MMF SystemJEY · Traditional | Stryker | 10/31/2012SE |
| K120951 | Smartbuilder SystemJEY · Traditional | Osstem Implant Co., Ltd. | 10/03/2012SE |
| K121589 | Biomet Microfixation Facial Plating SystemJEY · Special | Biomet Microfixation | 09/21/2012SE |
| K121574 | Synthes Matrixmadible Plate and Screw SystemJEY · Special | Synthes, Inc. | 06/29/2012SE |
| K113512 | Biomet Microfixation Mandibular Fracture/ Reconstruction Devices and Prebent Plates SystemJEY · Special | Biomet Microfixation | 06/29/2012SE |
| K120271 | Artisan Space Maintenance SystemJEY · Traditional | Medtronic Sofamor Danek USA, Inc. | 05/30/2012SE |
| K112457 | Leforte System Bone Plate & ScrewJEY · Special | Arkin Consulting Group | 05/18/2012SE |
| K112064 | Resorb X-GJEY · Traditional | KLS-Martin L.P. | 03/23/2012SE |
| K111761 | Neo Titanium Mesh, Cti-MemJEY · Traditional | Neobiotech Co., Ltd. | 01/10/2012SE |
| K113251 | Synthes Matrixmandible Performed Reconstruction PlatesJEY · Special | Synthes, Inc. | 12/21/2011SE |
| K110926 | Bone Plate; Bone ScrewJEY · Traditional | Biomaterials Korea, Inc. | 12/08/2011SE |
| K110259 | Architex Space Maintenance SystemJEY · Traditional | Medtronic Sofamor Danek USA, Inc. | 04/13/2011SE |
| K103136 | Surgicase CMF, Surgicase Connect, Surgicase GuideJEY · Traditional | Materialise NV | 03/18/2011SE |
| K103778 | Leforte Neuro System Bone PlateJEY · Special | Jeil Medical Corporation | 01/26/2011SE |
| K102656 | Synthes Dentoalveolar Bone Fixation SystemJEY · Traditional | Synthes (Usa) | 12/20/2010SE |
| K102641 | Mini and Micro Fragments Reconstruction System-NeofaceJEY · Traditional | Neoortho Produtos Ortopedicos S/A | 12/20/2010SE |
| K100779 | Sustain Space Maintenance SystemJEY · Traditional | Medtronic Sofamor Danek USA, Inc. | 12/13/2010SE |
| K091807 | Medpor Fixation SystemJEY · Traditional | Porex Surgical, Inc. | 06/28/2010SE |
| K091812 | Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…JEY · Traditional | Frontier Devices, Inc. | 05/07/2010SE |
| K092743 | The Leibinger Advance Internal Midface Distraction SystemJEY · Traditional | Stryker Craniomaxillofacial | 01/15/2010SE |
| K091233 | Synthes Matrixmandible Subcondylar PlatesJEY · Traditional | Synthes (Usa) | 12/11/2009SE |
| K091679 | Leforte System Bone PlateJEY · Traditional | Jeil Medical Corporation | 10/02/2009SE |
| K091144 | Synthes Matrixmandible Preformed Reconstruction PlatesJEY · Traditional | Synthes (Usa) | 08/25/2009SE |
| K083388 | Synthes Matrixorthognathis Fixation SystemJEY · Traditional | Synthes (Usa) | 03/12/2009SE |
| K082335 | Synthes Matrixmandible Plate and Screw SystemJEY · Traditional | Synthes (Usa) | 11/10/2008SE |
| K073307 | Max-Face Maxillofacial Osteosynthesis SystemJEY · Traditional | Bio-Technology USA, Inc. | 10/29/2008SE |
| K082757 | Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…JEY · Special | Bioplate, Inc. | 10/01/2008SE |
| K080862 | Sonicweld RX (Resorb-X)JEY · Traditional | KLS-Martin L.P. | 07/21/2008SE |
| K080694 | Osteomed Modular Locking Fixation SystemJEY · Traditional | Osteomed LP | 05/15/2008SE |
| K081067 | Fracture/Reconstruction System (Traumaone)JEY · Special | Biomet Microfixation, Inc. | 05/09/2008SE |
| K080331 | Synthes Craniofacial Plate and Screw SystemJEY · Traditional | Synthes (Usa) | 04/30/2008SE |
| K072528 | Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & AccessoriesJEY · Traditional | Prosurg, Inc. | 12/28/2007SE |
| K072463 | Satyrne Interflex Mandibular Fixation SystemJEY · Traditional | Satyrne Medical | 11/29/2007SE |
| K071612 | Modus Trilock 2.0/2.3/2.5JEY · Traditional | Medartis AG | 09/11/2007SE |
| K062436 | Sis Sinus Implant StabilizerJEY · Traditional | Mondeal Medical Systems GmbH | 07/30/2007SE |
| K070737 | Xsorb Bioabsorbable Craniofacial Bone Fixation System & AccessoriesJEY · Traditional | Prosurg, Inc. | 07/25/2007SE |
| K063790 | The Synthes Matrixmandible Plate and Screw SystemJEY · Traditional | Synthes (Usa) | 04/16/2007SE |
| K061881 | Osteotrans -Mx Bioabsorbable Bone Fixation SystemJEY · Traditional | Takiron Co., Ltd. | 03/14/2007SE |
| K062789 | Synthes (USA) Rapid Resorbable Fixation SystemJEY · Traditional | Synthes (Usa) | 02/27/2007SE |
| K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesJEY · Traditional | Walter Lorenz Surgical, Inc. | 01/12/2007SE |
| K061507 | Sonicweld RX Endobrow FixationJEY · Traditional | KLS-Martin L.P. | 09/21/2006SE |
| K060177 | KLS Martin Rigid Fixation - SterileJEY · Traditional | KLS Martin L.P. | 04/18/2006SE |
| K060492 | Aesculap Craniofacial Plate and ScrewJEY · Traditional | Aesculap, Inc. | 04/07/2006SE |
| K052444 | Inion CPS Baby 1.5 Bioabsorbable Fixation SystemJEY · Special | Inion , Ltd. | 09/20/2005SE |
| K051236 | Resorb-X SFJEY · Traditional | KLS-Martin L.P. | 08/22/2005SE |
| K051845 | The Bioplate Resorbable Endobrow Fixation SystemJEY · Special | Bioplate, Inc. | 07/27/2005SE |
| K051293 | Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemJEY · Traditional | Ceremed , Inc. | 06/14/2005SE |
| K051341 | Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058…JEY · Special | Inion , Ltd. | 05/27/2005SE |
| K050669 | Jeil Bone Fixation SystemJEY · Traditional | Jeil Medical Corporation | 05/26/2005SE |
| K050608 | Synthes Carniofacial Plate and Screw SystemJEY · Traditional | Synthes (Usa) | 05/18/2005SE |
| K050934 | Modus Titanium Osteosynthesis SystemJEY · Special | Medartis, Inc. | 05/05/2005SE |
| K050204 | Synthes Rapid Resorbable Tack SystemJEY · Traditional | Synthes (Usa) | 03/04/2005SE |
| K043297 | Medicon 2.4 Mandibular Reconstruction Plating SystemJEY · Special | Medicon EG | 02/23/2005SE |
| K042987 | Modification to Synthes Cranial PlatesJEY · Special | Synthes (Usa) | 11/23/2004SE |
| K042365 | Synthes (USA) Neuro Plate and Screw SystemJEY · Traditional | Synthes (Usa) | 11/18/2004SE |
| K042517 | Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsJEY · Special | Linvatec Biomaterials, Ltd. | 10/08/2004SE |
| K040650 | Bonamates SeriesJEY · Traditional | Biotech One, Inc. | 06/03/2004SE |
| K030425 | Lorenz Resorbable Distraction System or ExpanderJEY · Traditional | Walter Lorenz Surgical, Inc. | 05/14/2004SE |
| K033092 | The GnathometerJEY · Traditional | Ortho Gnathics, LLC | 04/21/2004SE |
| K030989 | Osteosorb Tack Fixation SystemJEY · Traditional | Noviace Corporation | 04/01/2004SE |
| K040272 | Synthes (USA) Craniofacial PlatesJEY · Special | Synthes (Usa) | 02/23/2004SE |
| K032520 | Ortrautek Trauma SystemJEY · Traditional | Tekka | 11/12/2003SE |
| K033194 | Inion CPS Baby 1.5 Bioabsorbable SystemJEY · Special | Inion , Ltd. | 10/30/2003SE |
| K031989 | Ortrautek Orthognathic SystemJEY · Traditional | Tekka | 10/28/2003SE |
| K033121 | 1.3 & 1.5MM Contourable Titanium (Ti.) Mesh PlatesJEY · Special | Synthes (Usa) | 10/20/2003SE |
| K033160 | Synthes Sterile Low Profile Neuro Contourable Mesh PlatesJEY · Special | Synthes (Usa) | 10/09/2003SE |
| K031659 | Universal Neuro SystemJEY · Traditional | Stryker Instruments | 09/10/2003SE |
| K031761 | Synthes (USA) New/Sterial Orbital PlatesJEY · Traditional | Synthes (Usa) | 09/03/2003SE |
| K030448 | Osteomed 2.0 Locking Plates and ScrewsJEY · Traditional | Osteomed LP | 05/09/2003SE |
| K031028 | The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryJEY · Special | Bioplate, Inc. | 04/28/2003SE |
| K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryJEY · Special | Bioplate, Inc. | 04/08/2003SE |
| K030069 | Synthes Poly (L-Lactide-Co-Glycolide) Resorbable Fixation SystemJEY · Traditional | Synthes (Usa) | 04/08/2003SE |
| K022035 | Osteomedics Resorbable Small Fixation System, OsteosorbJEY · Traditional | Osteomedics, Inc. | 01/17/2003SE |
| K022844 | Synthes Resorbable Contourable MeshJEY · Traditional | Synthes (Usa) | 01/07/2003SE |
| K022185 | Universal CMF SystemJEY · Traditional | Stryker Instruments | 12/17/2002SE |
| K023810 | Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…JEY · Special | Bioplate, Inc. | 12/04/2002SE |
| K023665 | Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryJEY · Special | Bioplate, Inc. | 11/22/2002SE |
| K022012 | Synthes Low Profile Neuro SystemJEY · Traditional | Synthes (Usa) | 11/01/2002SE |
| K023488 | Osstaple, CraniofacialJEY · Special | Biomedical Enterprises, Inc. | 10/31/2002SE |
| K023486 | Osstaple, MaxillofacialJEY · Special | Biomedical Enterprises, Inc. | 10/31/2002SE |
| K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…JEY · Special | Bioplate, Inc. | 09/06/2002SE |
| K021928 | Synthes (USA) Resorbable Fixation SystemJEY · Traditional | Synthes (Usa) | 09/06/2002SE |
| K022005 | Synthes Midface DistractorJEY · Traditional | Synthes (Usa) | 09/03/2002SE |
| K021642 | Synthes Craniofacial PlatesJEY · Traditional | Synthes (Usa) | 08/14/2002SE |
| K021618 | Osa Rigid Internal Fixation SystemJEY · Traditional | Osteomed Corp. | 08/08/2002SE |
| K021511 | Cytoflex MeshJEY · Traditional | Unicare Biomedical, Inc. | 08/06/2002SE |
| K021342 | Normed Bi-Directional/Multidirectional Jaw DistractorJEY · Traditional | Osteomedics, Inc. | 08/01/2002SE |
| K021341 | Normed Bone Transport Distraction DeviceJEY · Traditional | Osteomedics, Inc. | 08/01/2002SE |
| K022033 | Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…JEY · Special | Bioplate, Inc. | 07/19/2002SE |
| K021684 | The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryJEY · Traditional | Bioplate, Inc. | 06/26/2002SE |
| K021382 | Synthes (USA) Automated Tack DriverJEY · Special | Synthes (Usa) | 05/16/2002SE |
| K020505 | Synthes Translating Maxillary DistractorJEY · Traditional | Synthes (Usa) | 04/23/2002SE |
| K013672 | Bruges Distraction - Anchoring - Osteosynthesis SystemJEY · Traditional | Azary Technologies, LLC | 04/08/2002SE |
| K011590 | Resorb-X Resorbable Plating SystemJEY · Traditional | KLS-Martin L.P. | 03/20/2002SE |
| K014263 | Newgen/Universal Mandibular SystemJEY · Special | Stryker Instruments | 03/08/2002SE |
| K011569 | Biosorbfx O/M 2.0/2/4 SystemJEY · Traditional | Bionx Implants, Inc. | 02/22/2002SE |
| K020087 | Synthes Cranial PlatesJEY · Traditional | Synthes (Usa) | 02/20/2002SE |
| K013055 | The Bioplate Bioclip Craniotomy Fixation SystemJEY · Traditional | Bioplate, Inc. | 12/07/2001SE |
| K012910 | The Bioplate Mandible Fixation SystemJEY · Traditional | Bioplate, Inc. | 11/20/2001SE |
| K013039 | Inion CPS 2.0 Orthognathic PlateJEY · Special | Inion , Ltd. | 10/05/2001SE |
| K012413 | Macropore FX, PS, NS, LPJEY · Traditional | Macropore Biosurgery, Inc. | 09/18/2001SE |
| K011698 | Straumann GBR SystemJEY · Traditional | Institut Straumann AG | 08/23/2001SE |
| K010118 | Normed Mandibular Fixation SystemJEY · Traditional | Osteomedics, Inc. | 08/14/2001SE |
| K003281 | Lactosorb RapidflapJEY · Traditional | Biomet, Inc. | 08/07/2001SE |
| K002207 | Macroporepx Pediatric SystemJEY · Traditional | Macropore Biosurgery, Inc. | 07/11/2001SE |
| K011380 | Modification to the Bioplate Bioclip Craniotomy Fixation SystemJEY · Special | Bioplate, Inc. | 05/14/2001SE |
| K010499 | Synthes (USA) Midface DistractorJEY · Traditional | Synthes (Usa) | 05/03/2001SE |
| K010351 | Inion CPS Baby 1.5 Bioabsorbable Fixation SystemJEY · Traditional | Inion , Ltd. | 03/15/2001SE |
| K010687 | Biosorbfx and Biosorbpdx MeshJEY · Special | Bionx Implants, Inc. | 03/14/2001SE |
| K010352 | CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemJEY · Traditional | Inion , Ltd. | 03/14/2001SE |
| K003786 | SMF Resorbable Meshes and SheetsJEY · Traditional | Synthes (Usa) | 02/27/2001SE |
| K003549 | Codman Craniosorb Absorbable Fixation System Purple RivetsJEY · Traditional | Codman & Shurtleff, Inc. | 02/15/2001SE |
| K002083 | Lorenz Resorbable Distractor SystemJEY · Traditional | Walter Lorenz Surgical, Inc. | 02/12/2001SE |
| K003757 | Thermofx MeshJEY · Traditional | Bionx Implants, Ltd. | 02/07/2001SE |
| K002426 | The Bioplate Regid Fixation Bone Plating System for Cranomaxillofacial SurgeryJEY · Traditional | Bioplate, Inc. | 01/26/2001SE |
| K994060 | The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery, BiolactateJEY · Traditional | Bioplate, Inc. | 01/24/2001SE |
| K003883 | Molina Orbital Malar DistractorJEY · Traditional | KLS-Martin L.P. | 01/23/2001SE |
| K003393 | Maxillary DistractorJEY · Traditional | Synthes (Usa) | 01/17/2001SE |
| K000560 | Synthes (USA) Resorbable Tack SystemJEY · Traditional | Synthes (Usa) | 01/09/2001SE |
| K003756 | Biosorbfx Tack and Biosorbpdx Tack Bioabsorbable Fixation Fastener, Used with PlatesJEY · Special | Bionx Implants, Inc. | 01/03/2001SE |
| K003660 | Leibinger Neuro Clip SystemJEY · Special | Stryker Instruments | 12/12/2000SE |
| K000594 | Locking Screw Mandibular Reconstruction PlateJEY · Traditional | Stryker Leibinger | 12/08/2000SE |
| K002798 | Codman Craniosorb Absorbable Fixation System Drill BitsJEY · Traditional | Codman & Shurtleff, Inc. | 12/06/2000SE |
| K002619 | Newgen SystemJEY · Traditional | Stryker Instruments | 11/16/2000SE |
| K000696 | Macroporemx Mandibular Fixation SystemJEY · Traditional | Macropore Biosurgery, Inc. | 10/19/2000SE |
| K002879 | Modification to Bioplate Bioclip Craniotomy Fixation SystemJEY · Special | Bioplate, Inc. | 10/05/2000SE |
| K992905 | Codman Craniosorb Absorbable Fixation SystemJEY · Traditional | Codman & Shurtleff, Inc. | 08/01/2000SE |
| K001530 | The Bioplate Bioclip Craniotomy Fixation SystemJEY · Traditional | Bioplate, Inc. | 07/21/2000SE |
| K001219 | Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple SystemJEY · Traditional | Biomedical Ent., Inc. | 06/21/2000SE |
| K000836 | Biosorbpdx Bioabsorbable Fixation SystemJEY · Traditional | Bionx Implants, Inc. | 06/08/2000SE |
| K001238 | Lorenz Titanium Fracture / Reconstruction Plating SystemJEY · Special | Walter Lorenz Surgical, Inc. | 05/03/2000SE |
| K994154 | Mod Line of Molina Distractors, 51-600 SeriesJEY · Traditional | KLS-Martin L.P. | 02/15/2000SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2287-2023 Class II | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the…Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request | Materialise N.V. | 06/19/2023Completed |
| Z-0629-2021 Class II | Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | Biomet, Inc. | 11/25/2020Terminated |
| Z-2698-2020 Class II | MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of…One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The… | Synthes, Inc. | 06/18/2020Terminated |
| Z-2739-2020 Class II | MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of…One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip… | Synthes Produktions GmbH | 06/16/2020Terminated |
| Z-1485-2020 Class II | TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013Custom surgical kits contain a plate different than indicated by the package labeling. | Materialise N.V. | 02/03/2020Terminated |
| Z-1484-2020 Class II | TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001Custom surgical kits contain a plate different than indicated by the package labeling. | Materialise N.V. | 02/03/2020Terminated |
| Z-1705-2018 Class II | Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation…The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the… | Zimmer Biomet, Inc. | 04/05/2018Terminated |
| Z-1920-2016 Class II | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable…Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. | Synthes (USA) Products LLC | 05/02/2016Terminated |
| Z-1919-2016 Class II | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable…Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. | Synthes (USA) Products LLC | 05/02/2016Terminated |
| Z-1918-2016 Class II | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable…Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. | Synthes (USA) Products LLC | 05/02/2016Terminated |
| Z-2272-2015 Class II | Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI…The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the… | Synthes (USA) Products LLC | 06/24/2015Terminated |
| Z-0942-2013 Class II | Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary…There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly… | Synthes USA HQ, Inc. | 01/11/2013Terminated |
| Z-0108-2011 | 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. )…Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long… | Biomet Microfixation, Inc. | 08/31/2010Terminated |
| Z-2385-2011 | ***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218…Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120… | Biomet Microfixation, Inc. | 07/28/2010Terminated |
| Z-1286-2012 | Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE…On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left… | Biomet Microfixation, LLC | 04/26/2010Terminated |
| Z-0710-2011 | 2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1301, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0709-2011 | 2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1300, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0708-2011 | 2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1299, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0707-2011 | 2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0706-2011 | 2.8 mm Inion CPS, 2.8 x 10 mm screw, REF SCR-1297, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0705-2011 | 2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1294, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0704-2011 | 2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1293, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0703-2011 | 2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1292, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0702-2011 | 2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1291, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0701-2011 | 2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1290, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0700-2011 | 2.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0699-2011 | 2.0 mm Inion CPS, 2.0 x 17 mm screw, REF SCR-1288, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0698-2011 | 2.0 mm Inion CPS, 2.0 x 15 mm screw, REF SCR-1287, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0697-2011 | 2.0 mm Inion CPS, 2.0 x 13 mm screw, REF SCR-1286, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0696-2011 | 2.0 mm Inion CPS, 2.0 x 11 mm screw, REF SCR-1285, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0695-2011 | 2.0 mm Inion CPS, 2.0 x 9 mm screw, REF SCR-1284, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0694-2011 | 2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1243, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0693-2011 | 2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1242, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0692-2011 | 2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1241, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0691-2011 | 2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1240, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0690-2011 | 2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1239, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0689-2011 | 3.1 mm Inion CPS, 3.1 x 18 mm screw, REF SCR-1230, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0688-2011 | 3.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0687-2011 | 3.1 mm Inion CPS, 3.1 x 14 mm screw, REF SCR-1228, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0686-2011 | 3.1 mm Inion CPS, 3.1 x 12 mm screw, REF SCR-1227, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0685-2011 | 3.1 mm Inion CPS, 3.1 x 10 mm screw, REF SCR-1226, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0684-2011 | 2.0 mm Inion CPS, 2.0 x 7 mm screw, REF SCR-1225, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0683-2011 | 2.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0682-2011 | 1.5 mm Inion CPS, 1.5 x 6 mm screw, REF SCR-1223, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0681-2011 | 1.5 mm Inion CPS, 1.5 x 4 mm screw, REF SCR-1222, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0680-2011 | 1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0679-2011 | 1.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0678-2011 | 2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1216, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0677-2011 | 2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1215, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |
| Z-0676-2011 | 2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1214, sterile, Manufacturer, INION Oy…Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time… | Stryker Craniomaxillofacial Division | 04/14/2010Terminated |