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
+6K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+6K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+6K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+6K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+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
+6K142484Sternal Closure SystemJace Medical, LLC20141—
+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—
+6K133304RXG Distraction SystemKLS-Martin L.P.20140—
+6K133275Mini TightropeArthrex, Inc.201411—
+6K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+6K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+6K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+6K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+6K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+6K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+6K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+6K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+6K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+6K111032CMC Cable FixInstratek, Inc.20112—
+6K101484Compressyn BandDallen Medical20115—
+6K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+6K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+6K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+6K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+7K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+7K261511Xpert AnkleNewclip Technics20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K254182AsterOsteonic Co., Ltd.20260—
+7K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+7K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+7K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+7K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+7K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+7K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+7K243469SignexOsteonic Co., Ltd.20250—
+7K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+7K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+7K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+7K241539Activmotion SNewclip Technics20240—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+7K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+7K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+7K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+7K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+7K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+7K220966SinefixBAAT Medical Products B.V.20231—
+7K220757Argo Knotless SP AnchorConmed Corporation20226—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+7K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+7K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+7K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+7K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+7K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+7K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+7K202307Activ FuseNewclip Technics20200—
+7K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+7K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+7K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+7K193606Y-Knot OneStep AnchorConmed Corporation20200—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+7K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+7K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+7K191972ARIX Wrist SystemJeil Medical Corporation20190—
+7K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+7K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+7K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+7K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+7K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+7K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+7K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+7K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+7K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+7K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K171725CuffLink Implant SystemConmed Corporation20170—
+7K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+7K162198GFS UltimateParcus Medical, LLC20168—
+7K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+7K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+7K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—