510(k) Report

Devices descending from K002070

135 later devices reach Biolok Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+6K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+6K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+6K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+7K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+7K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+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—