510(k) Report

Devices descending from K915818

230 later devices reach Synthes (R) Titanium Small Reconstruction Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+5K153395OS2-C Compression StapleIn2bones Sas20167—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K151407RECON systemNormed Medizin-Technik GmbH20154—
+5K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+5K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+5K150626Rush Medullary PinsZimmer, Inc.20150—
+5K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+5K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+5K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+5K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K131061Restore Bunion Correction SystemNextremity Solutions201315—
+5K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+5K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+5K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+6K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+6K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+6K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+6K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+6K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+6K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K172886Breakaway Screw SystemParagon 2820174—
+6K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+6K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+6K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+6K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+6K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+6K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+6K163440Stealth Staple SystemFirst Ray, LLC20173—
+6K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+6K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+6K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+6K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+6K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+6K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+6K143365Eminent Foot Plate SystemEminent Spine20151—
+6K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+7K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+7K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+7K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+7K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+7K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+7K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+7K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+7K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+7K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+7K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+7K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—