510(k) Report

Devices descending from K953877

572 later devices reach Mitek Gii Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023963Adhoc ClawFuture Medical Systems, Inc.20031—
+1K012572Soft Tissue Screw and WasherBiomet, Inc.200147—
+1K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998166—
+1K980103Acumed Suture AnchorAcu Med, Inc.19980—
+1K973281The Surgical Dynamics* S.D. Sorb* E-Z Tac*United States Surgical, A Division of Tyco Healthc19970—
+1K971144Multitak SS Suture SystemBonutti Research19970—
+1K964324Multitak SS Suture SystemBonutti Research19970—
+1K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996531—
+2K081172Composite Hitch Suture AnchorBiomet Manufacturing Corp20080—
+2K080447Surgicraft Screw Fixation SystemSurgicraft, Ltd.20080—
+2K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077—
+2K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc.200791
+2K061657Hitch Lactosorb Suture AnchorArthrotek, Inc.20068—
+2K041274Resorbable Interference ScrewArthrotek, Inc.2004265
+2K040475Micromax Suture AnchorBiomet, Inc.200471
+2K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc.200415—
+2K024185BiodhocFuture Medical Systems, SA20040—
+2K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+2K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+2K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.199886—
+2K973015Multitak SS Suture SystemBonutti Research1997393—
+3K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+3K152262Ventix Knotless AnchorsBiomet Manufacturing Corp20160—
+3K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+3K110230Rog Knotless Suture AnchorRog Sports Medicine, Inc.20117—
+3K103145Hammerloc TM Tibial Fixation DeviceBiomet Sports Medicine201112
+3K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec20102—
+3K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.20103—
+3K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine201031
+3K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.20091—
+3K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.200868
+3K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142—
+3K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY20071—
+3K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc.20067—
+3K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+3K050468Triabsorb Composite ScrewAdvanced Biomaterials20050—
+3K052080Matryx Interference ScrewLinvatec Biomaterials, Inc.200513—
+3K042552Bio-Core Interference ScrewBiomet, Inc.20044—
+3K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+3K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—
+3K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+3K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+3K993115Multitak SSBonutti Research, Inc.19994—
+3K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+3K990156Multitak SS ButtonsBonutti Research1999336—
+3K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.19996—
+4K192949Flower Suture Anchor SetFlower Orthopedics Corporation20200—
+4K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200—
+4K192942ALLthread Titanium Suture AnchorBiomet, Inc.20200—
+4K193092TunneLoc Tibial Fixation DeviceBiomet, Inc.20200—
+4K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+4K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC20140—
+4K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+4K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC20141—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+4K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+4K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+4K113109Stryker Resorbable Fixation SystemStryker20113—
+4K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc.20115—
+4K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+4K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc.2011833
+4K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+4K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+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—
+4K083070Toggleloc SystemBiomet Sports Medicine2008946
+4K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+4K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+4K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc.20071—
+4K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+4K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials20073—
+4K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+4K051236Resorb-X SFKLS-Martin L.P.20056—
+4K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+4K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+4K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+4K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.20013—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+5K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+5K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+5K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+5K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+5K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants20222—
+5K203335MectaScrew ExtensionMedacta International S.A.20220—
+5K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+5K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+5K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+5K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—