510(k) Report

Devices descending from K954485

2 later devices reach 6.5MM Solid Cancellous Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—