510(k) Report

Devices descending from K053344

477 later devices reach Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+3K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140—
+3K103262Quickdraw Convertible Fixation Implant SystemTornier, Inc.20110—
+3K102660Bioraptor Curved 2.3 PK Suture AnchorsSmith & Nephew Endoscopy, Inc.20108—
+3K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+3K101448Opus Speedscrew SystemArthrocare Corp.2010101
+3K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp.20104—
+3K100457Opus Speedscrew SystemArthrocare Corp.201015—
+3K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.200941—
+3K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc.2009100—
+3K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+3K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.200921—
+3K083226Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc.20099—
+3K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc.2009159—
+3K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+3K072785Twinfix FT PKSmith & Nephew Inc., Endoscopy Division200759—
+4K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+4K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+4K251750Trax EX AnchorTrax Surgical, Inc.20260—
+4K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+4K260405FiberTape ButtonArthrex, Inc.20260—
+4K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+4K253695LigaMendRiverpoint Medical, LLC20260—
+4K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+4K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+4K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+4K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K250095All-Suture Dual Anchor SystemSuturetech, Inc.20250—
+4K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+4K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc.20254—
+4K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+4K251134RipCordTriMed, Inc.20250—
+4K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+4K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+4K243988RootMend MRRRiverpoint Medical, LLC20250—
+4K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+4K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+4K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+4K242091Bolo Button SystemFusion Orthopedics20240—
+4K240288SF Push- in AnchorSurgical Fusion Technologies GmbH20241—
+4K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+4K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+4K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+4K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+4K231857Arthrex TightRope IIArthrex, Inc.20234—
+4K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda.20231—
+4K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20231—
+4K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+4K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc.20231—
+4K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+4K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+4K220966SinefixBAAT Medical Products B.V.20231—
+4K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+4K220650TriMed Ripcord DeviceTriMed, Inc.202211
+4K213958Bioabsorbable AnchorEmbody, Inc.20220—
+4K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+4K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+4K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+4K211049Tigon Medical Button SystemTigon Medical20210—
+4K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20212—
+4K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+4K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20210—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K202883Sterile bone screw (PEEK ACL screw)Osteonic Co., Ltd.20200—
+4K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+4K200503ATL AnchorsInternational Life Sciences202022
+4K201749Arthrex SwiveLock AnchorArthrex, Inc.202015—
+4K201786Arthrex Mini Hip PushLockArthrex, Inc.20205—
+4K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+4K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+4K200341Arthrex FiberTak Suture AnchorArthrex, Inc.202017—
+4K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+4K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+4K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+4K191426FiberTak ButtonArthrex, Inc.20190—
+4K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+4K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+4K190892MectaScrew PEEK Interference ScrewMedacta International S.A.20191—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+4K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+4K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+4K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182—
+4K181262SpineJack Expansion KitVexim SA20184—
+4K173845Arthrex SwiveLockArthrex, Inc.20188—
+4K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+4K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+4K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+4K173278ToggleLoc SystemBiomet, Inc.20183—
+4K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials20172—
+4K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+4K172612FiberTak DXArthex, Inc.20170—