510(k) Report

Devices descending from K990454

119 later devices reach Bio-Interference Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+8K260405FiberTape ButtonArthrex, Inc.20260—
+8K253538TeKBrace Knotless AnchorTheramicro20260—
+8K253695LigaMendRiverpoint Medical, LLC20260—
+8K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+8K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+8K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+8K243988RootMend MRRRiverpoint Medical, LLC20250—
+8K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+8K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+8K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+8K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+8K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+8K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+8K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+8K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+9K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+9K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—