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
+6K243323Iconix Knotless AnchorRiverpoint Medical20240—
+6K240213Iconix Knotless AnchorRiverpoint Medical20240—
+6K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+6K230568FiberTak Suture AnchorArthrex, Inc.20236—
+6K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+6K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+6K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+6K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+6K220757Argo Knotless SP AnchorConmed Corporation20226—
+6K201648Sterispine™ PSSafe Orthopaedics202011
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+6K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+6K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+6K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+6K171582NEO Pedicle Screw System™Neo Medical SA20170—
+6K171725CuffLink Implant SystemConmed Corporation20170—
+6K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+6K170528Sterispine™ PSSafe Orthopaedics20172—
+6K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+6K153313SpeedLock Knotless Fixation SystemArthroCare Corporation20150—
+6K151921Sterispine PSSafe Orthopaedics20153—
+6K151747Sterispine PSSafe Orthopaedics20153—
+6K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+6K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics20154—
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K140802Sterispine PSSafe Orthopaedics20144—
+6K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+6K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K130632Sterispine PS Pedicle ScrewSafe Orthopaedics20135—
+6K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics20126—
+6K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+7K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+7K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+7K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+7K241577Iconix® AnchorRiverpoint Medical20240—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+7K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+7K233468Iconix AnchorRiverpoint Medical20231—
+7K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+7K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+7K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+7K202663Suture WingOsteonic Co., Ltd.20211—
+7K202375ZOLL Propaq MZOLL Medical Corporation20211—
+7K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+7K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+7K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+7K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+7K142915ZOLL X SeriesZOLL Medical Corporation20140—
+7K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+7K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+8K260405FiberTape ButtonArthrex, Inc.20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+8K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+8K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+8K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+8K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+8K233659Suture WingOsteonic Co., Ltd.20230—
+8K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+8K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+8K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+8K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—