510(k) Report

Devices descending from K971723

274 later devices reach Fastak Suture Anchor (11.7MM)/(7.5MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170098ICONIX TT All Suture AnchorStryker20173—
+4K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+4K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+4K151897MultiFIX® P Knotless Fixation DeviceArthroCare Corporation20150—
+4K151201Stryker ICONIX with NeedlesStryker201510—
+4K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20154—
+4K150166Extremity Medical Suture AnchorExtremity Medical, LLC20150—
+4K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc.20150—
+4K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+4K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+4K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+4K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+4K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.201229—
+4K111044Speedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped Obturator; Low Profile…ArthroCare Corporation20114—
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+4K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+4K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+4K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+4K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+4K102757Lifenet SystemPhysio-Control, Inc.20107—
+4K101437Speedfix Suture SystemArthrocare Corp.201012—
+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—
+4K091503Magnum MP Fixation DeviceArthrocare Corp.20090—
+4K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092—
+4K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+4K083240Opus MAGNUM2 and Opus Magnum X Knotless Fixation DevicesArthrocare Corp.200903
+4K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp.200816—
+4K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+4K080335Tornier Cinch Knotless Fixation Implant SystemTornier, Inc.20087—
+5K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+5K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+5K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+5K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+5K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+5K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+5K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+5K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+5K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+5K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+5K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+5K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+5K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+5K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+5K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+5K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+5K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC20170—
+5K172921Stryker Self-Punching ICONIXStryker20170—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+5K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+5K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+5K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+5K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+5K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+5K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation20133—
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+5K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+5K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp…Arthrocare Corp.20131—
+5K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+5K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+5K121865Zoll Rescuenet 12-LeadZOLL Medical Corporation20120—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+5K112453Sterispineps Pedicle ScrewSafe Orthopaedics201110—
+5K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+5K111296Zoll RescuenetlinkZoll Medical Corporation, World Wide Headquarters20115—
+5K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low…Arthrocare Corp.20110—
+5K101448Opus Speedscrew SystemArthrocare Corp.2010101
+5K100457Opus Speedscrew SystemArthrocare Corp.201015—
+5K091870Tornier, Piton Fixation Implant SystemTornier20096—
+6K262677Iconix Knotless TRiverpoint Medical20260—
+6K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+6K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—