510(k) Report

Devices descending from K061154

162 later devices reach Kinsa Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+4K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+4K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+4K203335MectaScrew ExtensionMedacta International S.A.20220—
+4K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+4K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+4K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+4K202393SpineJack Expansion KitStryker Corporation20203—
+4K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20200—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K190915OsteoFab Suture AnchorsOxford Performance Materials, Inc.20190—
+4K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+4K170877Parcus SLiK Fix ScrewParcus Medical20171—
+4K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+4K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc.20150—
+4K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+4K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+4K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+4K133671Iconix All Suture AnchorsStryker Corp.201425—
+4K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+4K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+4K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc.201111
+4K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+4K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+4K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div.2010174
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+5K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+5K241577Iconix® AnchorRiverpoint Medical20240—
+5K233468Iconix AnchorRiverpoint Medical20231—
+5K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+5K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+5K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+5K192810Apollo Suture Anchor SystemValeris Medical20201—
+5K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+5K171465Stryker Self-Punching ICONIXStryker20171—
+5K170098ICONIX TT All Suture AnchorStryker20173—
+5K152255BoneCam Suture AnchorsValeris Medical20151—
+5K151201Stryker ICONIX with NeedlesStryker201510—
+5K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc.20130—
+5K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+6K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+6K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+6K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+6K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+6K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+6K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+6K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+6K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+6K172921Stryker Self-Punching ICONIXStryker20170—
+6K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+7K262677Iconix Knotless TRiverpoint Medical20260—
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K243323Iconix Knotless AnchorRiverpoint Medical20240—
+7K240213Iconix Knotless AnchorRiverpoint Medical20240—