510(k) Report

Devices descending from K130625

3 later devices reach 12MM and 13MM Tibial Nails through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+1K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+2K243890Arthrex Intramedullary NailsArthrex, Inc.20250—