510(k) Report

Devices descending from K973758

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+5K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+5K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+5K160548MC-Subtalar (TM) IIMerete Medical GmbH20160—
+5K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+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—
+5K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+5K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+5K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+5K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+5K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+5K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+5K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+5K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+5K090107Mini TightropeArthrex, Inc.200921—
+5K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+5K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+5K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+5K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+5K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K253115Lars AcjMovmedix S.A.S.20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+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—
+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—
+6K231857Arthrex TightRope IIArthrex, Inc.20234—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, 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—
+6K220757Argo Knotless SP AnchorConmed Corporation20226—
+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—
+6K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+6K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+6K192984APTUS Clavicle SystemMedartis AG20206—
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+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—
+6K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+6K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+6K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+6K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+6K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+6K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173278ToggleLoc SystemBiomet, Inc.20183—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K171725CuffLink Implant SystemConmed Corporation20170—
+6K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+6K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+6K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+6K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+6K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+6K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+6K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+6K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+6K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+6K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+6K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+6K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+6K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+6K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+6K133275Mini TightropeArthrex, Inc.201411—