510(k) Report

Devices descending from K091566

16 later devices reach Zimmer Natural Nail System Cephalomedullary Nails through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+1K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+1K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20194—
+1K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+1K140601Flow-NailFlow-Fx, LLC20142—
+1K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+2K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+2K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+2K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+2K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+2K221115Flow-NailFlow-Fx, LLC20221—
+2K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+3K234075Flow-NailFlow-Fx, LLC20240—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K222309Gamma4 SystemStryker GmbH20220—