510(k) Report

Devices descending from K071177

227 later devices reach Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251750Trax EX AnchorTrax Surgical, Inc.20260—
+4K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+4K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+4K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+4K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+4K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc.20254—
+4K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+4K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+4K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+4K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+4K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda.20231—
+4K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc.20231—
+4K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+4K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K213958Bioabsorbable AnchorEmbody, Inc.20220—
+4K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+4K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+4K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20212—
+4K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+4K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+4K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K201749Arthrex SwiveLock AnchorArthrex, Inc.202015—
+4K201786Arthrex Mini Hip PushLockArthrex, Inc.20205—
+4K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+4K200341Arthrex FiberTak Suture AnchorArthrex, Inc.202017—
+4K191426FiberTak ButtonArthrex, Inc.20190—
+4K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+4K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K173845Arthrex SwiveLockArthrex, Inc.20188—
+4K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+4K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+4K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+4K172612FiberTak DXArthex, Inc.20170—
+4K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+4K151230Arthrex FiberTak AnchorsArthrex, Inc.201527—
+4K133671Iconix All Suture AnchorsStryker Corp.201425—
+4K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+4K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+4K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+5K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.20260—
+5K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+5K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.20260—
+5K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+5K253040Aevumed FASE Suture AnchorAevumed, Inc.20253—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+5K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20240—
+5K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+5K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+5K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20231—
+5K231326Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd.20231—
+5K223284SutureLoc™ ImplantArthrex, Inc.20230—
+5K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+5K221364Mitek TIGHT-N AnchorMedos International SARL20220—
+5K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+5K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+5K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+5K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+5K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+5K171465Stryker Self-Punching ICONIXStryker20171—
+5K170098ICONIX TT All Suture AnchorStryker20173—
+5K160319FiberTak DRArthrex, Inc.20160—
+5K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+5K151201Stryker ICONIX with NeedlesStryker201510—
+6K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+6K260405FiberTape ButtonArthrex, Inc.20260—
+6K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+6K253695LigaMendRiverpoint Medical, LLC20260—
+6K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+6K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+6K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+6K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+6K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+6K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+6K243988RootMend MRRRiverpoint Medical, LLC20250—
+6K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+6K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20240—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+6K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+6K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+6K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+6K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+6K231278Knotless Suture AnchorRiverpoint Medical, LLC202331