510(k) Report

Devices descending from K972326

488 later devices reach Peba Anchor/Suture Combination through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K131850Tensyn BandDallen Medical, Inc.20135—
+4K132461A.I.M. Suture AnchorAnchor Innovation Medical, Inc.20130—
+4K131769Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MMPivot Medical, Inc.2013122
+4K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+4K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc.20133—
+4K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+4K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+4K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+4K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+4K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+4K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+4K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+4K122059All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…Smith & Nephew, Inc.201316
+4K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+4K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+4K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+4K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc.20120—
+4K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc.20120—
+4K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+4K120509Stryker All Suture AnchorsStryker201227—
+4K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+4K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+4K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+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—
+4K053339Allofix AnchorMusculoskeletal Transplant Foundation20060—
+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—
+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—