510(k) Report

Devices descending from K041713

84 later devices reach Super Revo Herculine Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191677MectaTap TI Suture AnchorMedacta International S.A.20200—
+1K191300MectaLock Ti Suture AnchorMedacta International S.A.20193—
+1K073481Threvo Anchor, Disposable Driver, HI-FI SuturesConmed Linvatec200857—
+1K071375Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd.20070—
+1K061294KFX Knotless Fixation SystemKfx Medical200619—
+2K223582MectaLock TI Triple Loaded Suture AnchorMedacta International S.A.20232—
+2K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+2K072063KFX Tissue Fixation System and AccessoriesKfx Medical200718—
+3K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+3K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+3K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+3K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+3K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+3K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+3K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+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—
+4K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+4K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+4K220757Argo Knotless SP AnchorConmed Corporation20226—
+4K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+4K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+4K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+4K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+4K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+4K180759SECULOK™ Suture AnchorU&I Corporation20180—
+4K171725CuffLink Implant SystemConmed Corporation20170—
+4K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+4K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+4K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+4K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+4K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+4K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+5K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+5K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+5K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+5K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+5K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+5K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+5K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+5K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+5K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+5K193606Y-Knot OneStep AnchorConmed Corporation20200—
+5K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+5K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+5K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+5K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+5K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+6K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+6K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+6K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+6K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+6K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+6K202663Suture WingOsteonic Co., Ltd.20211—
+6K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+6K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+6K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+6K171465Stryker Self-Punching ICONIXStryker20171—
+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—
+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—
+6K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+7K233659Suture WingOsteonic Co., Ltd.20230—
+7K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+7K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+7K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+7K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+7K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+7K172921Stryker Self-Punching ICONIXStryker20170—
+8K241912BiochargeNanofiber Solutions, LLC20240—
+8K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+8K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—