510(k) Report

Devices descending from K011529

11 later devices reach T2 Humeral Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033878Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace200410—
+2K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+2K181827Affixus Natural Nail System Humeral NailZimmer GmbH20186—
+2K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+3K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH20201—
+4K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+5K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+5K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—