510(k) Report

Devices descending from K871037

10 later devices reach Cancellous Fixation Screw & Washer for Use W/Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122437NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc WashersBiomet Sports Medicine20134—
+1K981967Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System…Arthrotek/Biomet, Inc.19985—
+1K961649Acufex Tibial Anchor Screw & Spiked WasherSmith & Nephew Endoscopy, Inc.19963—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K994202Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and…Smith & Nephew, Inc.20001—
+2K983906Depuy Orthotech Spiked WasherDePuy Orthopaedics, Inc.19980—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+3K183628Arthrex TensionLoc SystemArthrex, Inc.20190—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—