510(k) Report

Devices descending from K231114

4 later devices reach Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+1K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+2K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+2K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—