510(k) Report

Devices descending from K133224

12 later devices reach Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+1K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+1K202663Suture WingOsteonic Co., Ltd.20211—
+1K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+1K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+1K171465Stryker Self-Punching ICONIXStryker20171—
+2K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+2K233659Suture WingOsteonic Co., Ltd.20230—
+2K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+2K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+2K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+2K172921Stryker Self-Punching ICONIXStryker20170—