510(k) Report

Devices descending from K952471

501 later devices reach Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation Rod through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd.20041—
+1K023022Nugen FX ScrewBionx Implants, Inc.20022—
+1K020222Wisorb Malleolar ScrewCambridge Scientific, Inc.20022—
+1K012001SmartscrewBionx Implants, Ltd.2001337—
+1K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999413—
+1K972919Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift ScrewBionx Implants, Inc.199887—
+2K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080—
+2K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050—
+2K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc.200501
+2K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd.20041—
+2K040265Little Grafter ScrewBiocomposites, Ltd.20041—
+2K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003333—
+2K013057Biocuff,C, Models 236018, 236028, 236036Bionx Implants, Inc.200179—
+2K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.199886—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+3K081392Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinBioretec, Ltd.20082—
+3K062980ActivascrewBioretec, Ltd.20061—
+3K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd.20063—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+3K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—
+3K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+3K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+3K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+3K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+3K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+3K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.19996—
+4K261057ActivaScrew™ Cannulated COMBioretec, Ltd.20260—
+4K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+4K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+4K203105Inion CompressOn ScrewInion OY20210—
+4K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+4K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+4K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+4K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+4K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K173910Impress SFS SystemCable Fix Medical, LLC20180—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+4K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+4K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+4K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+4K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+4K150359Tensyn PlugDallen Medical, Inc.20150—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K131850Tensyn BandDallen Medical, Inc.20135—
+4K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+4K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+4K113109Stryker Resorbable Fixation SystemStryker20113—
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K083070Toggleloc SystemBiomet Sports Medicine2008946
+4K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+4K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+4K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+4K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+4K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+4K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+4K051236Resorb-X SFKLS-Martin L.P.20056—
+4K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+4K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+5K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+5K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+5K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+5K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+5K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+5K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+5K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+5K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+5K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+5K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+5K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+5K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+5K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+5K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+5K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+5K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants20222—
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+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—
+5K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+5K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+5K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+5K180243Infinity-Lock Button SystemXiros, Ltd.20180—