510(k) Report

Devices descending from K960516

197 later devices reach Fastak Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077—
+1K061294KFX Knotless Fixation SystemKfx Medical200619—
+1K983557Stryker Wedge Suture AnchorStryker Endoscopy199812
+1K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998166—
+2K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+2K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.20103—
+2K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.20091—
+2K072063KFX Tissue Fixation System and AccessoriesKfx Medical200718—
+2K041310Stryker Wedge Suture Anchor SystemStryker Endoscopy20040—
+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—
+3K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC20140—
+3K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC20141—
+3K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+3K081598Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce SutureKfx Medical200816—
+3K0802295.5 MM Suture Lock Bone Screw AnchorKfx Medical20080—
+3K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+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—
+3K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+3K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.19996—
+4K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+4K113109Stryker Resorbable Fixation SystemStryker20113—
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+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—
+4K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+4K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+4K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+4K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+4K051236Resorb-X SFKLS-Martin L.P.20056—
+4K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+5K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+5K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+5K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+5K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants20222—
+5K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+5K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson201501
+5K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+5K121606Resorb-X GKLS-Martin L.P.20130—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K112064Resorb X-GKLS-Martin L.P.20122—
+5K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+5K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+5K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+5K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+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—
+6K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+6K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+6K220757Argo Knotless SP AnchorConmed Corporation20226—
+6K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+6K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+6K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+6K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+6K171725CuffLink Implant SystemConmed Corporation20170—
+6K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+6K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+6K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+6K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+6K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+6K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+6K142484Sternal Closure SystemJace Medical, LLC20141—
+6K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+6K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+6K133304RXG Distraction SystemKLS-Martin L.P.20140—
+6K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+6K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+6K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+6K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+6K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+6K101484Compressyn BandDallen Medical20115—