510(k) Report

Devices descending from K926384

539 later devices reach Statak & Mini-Statak Soft Tissue Attachment Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077—
+1K980595Depuy Orthotech Catera Suture AnchorDePuy Orthopaedics, Inc.19980—
+1K980103Acumed Suture AnchorAcu Med, Inc.19980—
+1K963502Csco Forehead Fixation SystemHowmedica Corp.19970—
+1K973015Multitak SS Suture SystemBonutti Research1997393—
+1K971144Multitak SS Suture SystemBonutti Research19970—
+1K963932Preloaded Soft Tissue AnchorLinvatec Corp.19971—
+1K963369Bio-AnchorLinvatec Corp.199781—
+1K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996531—
+2K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+2K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.20103—
+2K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine201031
+2K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.20091—
+2K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.200868
+2K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142—
+2K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+2K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+2K993115Multitak SSBonutti Research, Inc.19994—
+2K990770Biorc AnchorLinvatec Corp.19990—
+2K990156Multitak SS ButtonsBonutti Research1999336—
+2K983186Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp.199880—
+2K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998166—
+3K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200—
+3K192942ALLthread Titanium Suture AnchorBiomet, Inc.20200—
+3K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+3K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC20140—
+3K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC20141—
+3K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+3K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+3K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+3K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc.2011833
+3K083070Toggleloc SystemBiomet Sports Medicine2008946
+3K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+3K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+3K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+3K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+3K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.20013—
+3K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.199886—
+4K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+4K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+4K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+4K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+4K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+4K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+4K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+4K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+4K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K131850Tensyn BandDallen Medical, Inc.20135—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+4K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+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—
+4K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+4K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+4K100652Acl TightropeArthrex, Inc.201065—
+4K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+4K090107Mini TightropeArthrex, Inc.200921—
+4K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+4K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+4K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+4K081348Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc.20081—
+4K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+4K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+4K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation200601
+4K052901Arthrex TensionlokArthrex, Inc.20050—
+4K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+4K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation20041—
+4K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—
+4K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+4K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+4K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+4K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.19996—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K251134RipCordTriMed, Inc.20250—
+5K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+5K242091Bolo Button SystemFusion Orthopedics20240—
+5K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+5K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K220966SinefixBAAT Medical Products B.V.20231—
+5K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+5K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+5K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—