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
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+5K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+5K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson201501
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K143139Arthrex Fracture SystemArthrex, Inc.20151—
+5K141420FastforwardMedShape, Inc.20145—
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+5K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+5K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+5K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+5K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+5K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+5K121606Resorb-X GKLS-Martin L.P.20130—
+5K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+5K112064Resorb X-GKLS-Martin L.P.20122—
+5K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+5K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+5K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+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—
+5K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+5K090107Mini TightropeArthrex, Inc.200921—
+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—
+5K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+5K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+5K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+5K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+5K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+5K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+5K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+5K061507Sonicweld RX Endobrow FixationKLS-Martin L.P.20060—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+6K253115Lars AcjMovmedix S.A.S.20260—
+6K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+6K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K251134RipCordTriMed, Inc.20250—
+6K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+6K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+6K242091Bolo Button SystemFusion Orthopedics20240—
+6K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+6K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+6K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+6K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+6K230546SignexOsteonic Co., Ltd.20242—
+6K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+6K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+6K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K231857Arthrex TightRope IIArthrex, Inc.20234—
+6K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+6K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+6K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+6K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+6K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+6K212739ActiFlipParcus Medical, LLC20210—
+6K211049Tigon Medical Button SystemTigon Medical20210—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+6K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+6K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+6K192984APTUS Clavicle SystemMedartis AG20206—
+6K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+6K191426FiberTak ButtonArthrex, Inc.20190—
+6K190143LARS AC Band DeviceCorin USA20191—
+6K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+6K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+6K191204Infinity Fixation SystemConmed Corporation20190—
+6K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+6K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+6K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+6K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+6K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+6K180759SECULOK™ Suture AnchorU&I Corporation20180—
+6K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173278ToggleLoc SystemBiomet, Inc.20183—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+6K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+6K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+6K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+6K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—