510(k) Report

Devices descending from K961555

584 later devices reach Acufex Tag Bioabsorbable Anchors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+5K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC20141—
+5K140925Acumed Suture Anchor SystemAcumed, LLC20140—
+5K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+5K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+5K133858Tensyn BandDallen Medical, Inc.20143—
+5K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+5K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+5K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+5K131850Tensyn BandDallen Medical, Inc.20135—
+5K132461A.I.M. Suture AnchorAnchor Innovation Medical, Inc.20130—
+5K131769Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MMPivot Medical, Inc.2013122
+5K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+5K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc.20133—
+5K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+5K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+5K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+5K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+5K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+5K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+5K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+5K122059All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…Smith & Nephew, Inc.201316
+5K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+5K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+5K121606Resorb-X GKLS-Martin L.P.20130—
+5K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+5K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc.20120—
+5K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc.20120—
+5K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K120509Stryker All Suture AnchorsStryker201227—
+5K112064Resorb X-GKLS-Martin L.P.20122—
+5K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+5K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+5K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+5K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+5K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+5K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc.20115—
+5K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+5K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140—
+5K103262Quickdraw Convertible Fixation Implant SystemTornier, Inc.20110—
+5K102660Bioraptor Curved 2.3 PK Suture AnchorsSmith & Nephew Endoscopy, Inc.20108—
+5K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+5K101448Opus Speedscrew SystemArthrocare Corp.2010101
+5K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp.20104—
+5K100457Opus Speedscrew SystemArthrocare Corp.201015—
+5K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.200941—
+5K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc.2009100—
+5K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+5K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.200921—
+5K083226Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc.20099—
+5K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc.2009159—
+5K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+5K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+5K072785Twinfix FT PKSmith & Nephew Inc., Endoscopy Division200759—
+5K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+5K061507Sonicweld RX Endobrow FixationKLS-Martin L.P.20060—
+6K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+6K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+6K251750Trax EX AnchorTrax Surgical, Inc.20260—
+6K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+6K260405FiberTape ButtonArthrex, Inc.20260—
+6K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+6K253695LigaMendRiverpoint Medical, LLC20260—
+6K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+6K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+6K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+6K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+6K250095All-Suture Dual Anchor SystemSuturetech, Inc.20250—
+6K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+6K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc.20254—
+6K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+6K251134RipCordTriMed, Inc.20250—
+6K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+6K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+6K243988RootMend MRRRiverpoint Medical, LLC20250—
+6K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+6K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+6K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+6K242091Bolo Button SystemFusion Orthopedics20240—
+6K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+6K240288SF Push- in AnchorSurgical Fusion Technologies GmbH20241—
+6K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+6K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+6K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+6K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K231857Arthrex TightRope IIArthrex, Inc.20234—
+6K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda.20231—
+6K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20231—
+6K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+6K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc.20231—
+6K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+6K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—