510(k) Report

Devices descending from K973758

416 later devices reach Bioscrew Absorbable Interference Srew through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials20073—
+1K051611Mbaresorb ImplantKinetikos Medical, Inc.2005103
+1K031939Bio-Eurolig Interference ScrewFournitures Hospitalieres Industrie20040—
+1K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc.200415—
+1K021280Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd.20021—
+1K013131Bioscrew XtralokLinvatec Corp.2002771
+1K013781Rididfix 2.7MM BTB Cross Pin KitMitek Products20023—
+1K993166Stryker Bioabsorbable Interference Screw SystemStryker Endoscopy200011
+1K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Bionx Implants, Ltd.199916—
+1K990194BiobuttonLinvatec Corp.1999310—
+2K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec20102—
+2K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies20108—
+2K092998Conmed Linvatec Intercept ImplantLinvatec Corp.20090—
+2K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company20092—
+2K071456Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc.20089—
+2K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc.20071—
+2K060393Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd.20060—
+2K050468Triabsorb Composite ScrewAdvanced Biomaterials20050—
+2K052080Matryx Interference ScrewLinvatec Biomaterials, Inc.200513—
+2K050497Bioscrew Xtralok, 8X35MM & 8X40MM VioletLinvatec Corp.200576—
+2K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+2K033252Modification to Stryker Bioabsorbable Interference Screw SystemStryker Endoscopy20030—
+3K203335MectaScrew ExtensionMedacta International S.A.20220—
+3K140962Normed Vario Subtalar ScrewNormed Nedizin Technik GmbH20140—
+3K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+3K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC20122—
+3K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+3K111834Disco Subtalar ImplantTrilliant Surgical, Ltd.201131
+3K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd.201141
+3K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+3K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…Depuy Mitek, A Johnson & Johnson Company20091—
+3K081348Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc.20081—
+3K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+4K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+4K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+4K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+4K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+4K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K173910Impress SFS SystemCable Fix Medical, LLC20180—
+4K180759SECULOK™ Suture AnchorU&I Corporation20180—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+4K170688PIT’Stop® implantIn2bones Sas20171—
+4K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+4K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+4K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+4K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+4K150359Tensyn PlugDallen Medical, Inc.20150—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH20132—
+4K131850Tensyn BandDallen Medical, Inc.20135—
+4K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+4K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+4K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+4K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+4K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+4K083070Toggleloc SystemBiomet Sports Medicine2008946
+4K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+4K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+4K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+5K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+5K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+5K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+5K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+5K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+5K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+5K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+5K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+5K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+5K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+5K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K180243Infinity-Lock Button SystemXiros, Ltd.20180—