510(k) Report

Devices descending from K001945

112 later devices reach Synthes (Usa) Medial Distal Tibia Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+1K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K140098Emerge Medical Small Fragment Locked Plating SystemEmerge Medical20140—
+1K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+1K102282The Varia Fibula Locked Plating System Line Extension Addition of Straight PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201077—
+1K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+1K052011Pilonplate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200511
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K132502Variax 2 SystemStryker Trauma AG201321—
+2K123000Integra Total Foot SystemsIntegra LifeSciences Corporation201254—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K173746Activmotion RangeNewclip Technics20181—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K163293Colink™ Plating SystemIn2bones USA, LLC2017212
+3K140769Variax 2 SystemStryker Trauma AG201419—
+3K132594Crosscheck Plating SystemSolana Surgical, LLC20132321
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+4K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K173135VariAx 2 SystemStryker GmbH201713—
+4K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+5K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K180500VariAx 2 SystemStryker GmbH201812—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K211843PolyLock Plating SystemFusion Orthopedics20220—