510(k) Report

Devices descending from K102282

77 later devices reach The Varia Fibula Locked Plating System Line Extension Addition of Straight… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132502Variax 2 SystemStryker Trauma AG201321—
+1K123000Integra Total Foot SystemsIntegra LifeSciences Corporation201254—
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K173556Injection ScrewBiedermann Medtech, Inc.20180—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K163293Colink™ Plating SystemIn2bones USA, LLC2017212
+2K140769Variax 2 SystemStryker Trauma AG201419—
+2K132594Crosscheck Plating SystemSolana Surgical, LLC20132321
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+3K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K173135VariAx 2 SystemStryker GmbH201713—
+3K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+3K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+3K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+4K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K180500VariAx 2 SystemStryker GmbH201812—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K211843PolyLock Plating SystemFusion Orthopedics20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—