510(k) Report

Devices descending from K961649

3 later devices reach Acufex Tibial Anchor Screw & Spiked Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994202Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and…Smith & Nephew, Inc.20001—
+1K983906Depuy Orthotech Spiked WasherDePuy Orthopaedics, Inc.19980—
+2K183628Arthrex TensionLoc SystemArthrex, Inc.20190—