510(k) Report

Devices descending from K031685

478 later devices reach Tag Rod Bioraptor Suture Anchor 7209317, 7209318 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc.20115—
+4K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+4K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140—
+4K103262Quickdraw Convertible Fixation Implant SystemTornier, Inc.20110—
+4K102660Bioraptor Curved 2.3 PK Suture AnchorsSmith & Nephew Endoscopy, Inc.20108—
+4K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+4K101448Opus Speedscrew SystemArthrocare Corp.2010101
+4K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp.20104—
+4K100457Opus Speedscrew SystemArthrocare Corp.201015—
+4K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.200941—
+4K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc.2009100—
+4K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+4K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.200921—
+4K083226Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc.20099—
+4K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc.2009159—
+4K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+4K072785Twinfix FT PKSmith & Nephew Inc., Endoscopy Division200759—
+5K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K251750Trax EX AnchorTrax Surgical, Inc.20260—
+5K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+5K253695LigaMendRiverpoint Medical, LLC20260—
+5K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+5K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K250095All-Suture Dual Anchor SystemSuturetech, Inc.20250—
+5K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+5K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc.20254—
+5K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+5K251134RipCordTriMed, Inc.20250—
+5K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+5K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+5K243988RootMend MRRRiverpoint Medical, LLC20250—
+5K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+5K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+5K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+5K242091Bolo Button SystemFusion Orthopedics20240—
+5K240288SF Push- in AnchorSurgical Fusion Technologies GmbH20241—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+5K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+5K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda.20231—
+5K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20231—
+5K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+5K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc.20231—
+5K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+5K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+5K220966SinefixBAAT Medical Products B.V.20231—
+5K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K213958Bioabsorbable AnchorEmbody, Inc.20220—
+5K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+5K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K211049Tigon Medical Button SystemTigon Medical20210—
+5K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20212—
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+5K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+5K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20210—
+5K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+5K202883Sterile bone screw (PEEK ACL screw)Osteonic Co., Ltd.20200—
+5K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+5K200503ATL AnchorsInternational Life Sciences202022
+5K201749Arthrex SwiveLock AnchorArthrex, Inc.202015—
+5K201786Arthrex Mini Hip PushLockArthrex, Inc.20205—
+5K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+5K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+5K200341Arthrex FiberTak Suture AnchorArthrex, Inc.202017—
+5K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+5K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K191426FiberTak ButtonArthrex, Inc.20190—
+5K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+5K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+5K190892MectaScrew PEEK Interference ScrewMedacta International S.A.20191—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+5K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182—
+5K181262SpineJack Expansion KitVexim SA20184—
+5K173845Arthrex SwiveLockArthrex, Inc.20188—
+5K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials20172—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—