510(k) Report

Devices descending from K131035

17 later devices reach Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+1K193606Y-Knot OneStep AnchorConmed Corporation20200—
+1K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+1K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+2K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+2K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+2K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+2K202663Suture WingOsteonic Co., Ltd.20211—
+2K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+2K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+2K171465Stryker Self-Punching ICONIXStryker20171—
+3K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+3K233659Suture WingOsteonic Co., Ltd.20230—
+3K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+3K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+3K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+3K172921Stryker Self-Punching ICONIXStryker20170—