510(k) Report

Devices descending from K081546

116 later devices reach Small Bone Locking Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc.20200—
+1K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+1K192473Exsomed Wrist Plating SystemExsomed Corporation20190—
+1K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+1K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+1K140622DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna PlateBiomet, Inc.201401
+1K140372Fragment Plate SystemSkeletal Dynamics, LLC20142—
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K111266Easylock OsteosystemTriMed, Inc.20110—
+1K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+1K0833642.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking…DePuy Orthopaedics, Inc.200890—
+2K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+2K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+2K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+2K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+2K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+2K213214Xpert WristNewclip Technics20210—
+2K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+2K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+2K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+2K143721PRCT2Fx Solutions20150—
+2K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+2K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+2K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+3K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+3K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+3K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+3K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+4K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+5K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K191867ATLAS Plating SystemMiRus, LLC20200—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+5K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+5K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+5K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—