510(k) Report

Devices descending from K953644

438 later devices reach Volar Distal Radius Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K1101252.4 MM VA-LCP Volar Rim Distal Radius SystemSynthes USA20115—
+1K990596Distal Radius Fracture Fixation Plate SystemAvanta Orthopaedics, Inc.19990—
+1K981715Distal Radius Fracture Fixation PlateAvanta Orthopaedics, Inc.19981—
+1K974876Bionx Distal Radius ScrewBionx Implants, Inc.1998419—
+1K972219Orthopedic Plate SystemFerguson Medical19978—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes…Gpc Medical Limited20220—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050—
+2K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd.20041—
+2K023022Nugen FX ScrewBionx Implants, Inc.20022—
+2K022139Hip Tool ImplantOrthopedic Sciences, Inc.20027—
+2K020222Wisorb Malleolar ScrewCambridge Scientific, Inc.20022—
+2K020819Distal Radius Plating SystemBiomet, Inc.20021—
+2K013057Biocuff,C, Models 236018, 236028, 236036Bionx Implants, Inc.200179—
+2K012001SmartscrewBionx Implants, Ltd.2001337—
+2K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999413—
+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—
+3K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080—
+3K063709TS-Bone Hip ToolOrthopedic Sciences, Inc.20071—
+3K052624Inion Otps Biodegradable Distal Radius PlateInion, Ltd.20050—
+3K052538S-Bone Hip ToolOrthopedic Sciences, Inc.20050—
+3K051032Titanium-Hip ToolOrthopedic Sciences, Inc.20050—
+3K051181Custom-Hip ToolOrthopedic Sciences, Inc.20050—
+3K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc.200501
+3K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd.20041—
+3K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc.20041—
+3K040265Little Grafter ScrewBiocomposites, Ltd.20041—
+3K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003333—
+3K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+3K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+4K081392Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinBioretec, Ltd.20082—
+4K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc.20070—
+4K062980ActivascrewBioretec, Ltd.20061—
+4K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc.20060—
+4K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd.20063—
+4K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+4K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+4K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+5K261057ActivaScrew™ Cannulated COMBioretec, Ltd.20260—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+5K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K203105Inion CompressOn ScrewInion OY20210—
+5K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+5K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+5K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+5K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+5K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+5K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+5K173910Impress SFS SystemCable Fix Medical, LLC20180—
+5K171703PUMA SystemPanther Orthopedics, Inc.20180—
+5K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+5K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+5K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+5K150359Tensyn PlugDallen Medical, Inc.20150—
+5K133858Tensyn BandDallen Medical, Inc.20143—
+5K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+5K131850Tensyn BandDallen Medical, Inc.20135—
+5K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+5K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+5K112437Arthrex Fracture SystemArthrex, Inc.201191—
+5K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+5K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+5K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+5K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+5K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+5K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+5K083070Toggleloc SystemBiomet Sports Medicine2008946
+5K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+5K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+5K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+5K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+6K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+6K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+6K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+6K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+6K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+6K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+6K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+6K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+6K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—