510(k) Report

Devices descending from K101622

29 later devices reach Zimmer Natural Nail System Retrograde Femoral Nails through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+1K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+1K191238Zimmer Guide Wire DevicesZimmer, Inc.20190—
+1K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+1K172114Zimmer Natural Nail SystemZimmer, Inc.201711—
+1K142281Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc.2014107
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+2K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+2K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+2K230512Gamma4 SystemStryker GmbH20230—
+2K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+2K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+2K210285Adaptable Ortho Innovations Intramedullary Nail SystemAdaptable Ortho Innovations, LLC20210—
+2K200869Gamma3 SystemStryker Trauma GmbH20209—
+2K181827Affixus Natural Nail System Humeral NailZimmer GmbH20186—
+2K181375Apex Femoral Nailing SystemOrthoxel20180—
+2K143321ITST Intertrochanteric/Subtrochanteric Fixation SystemZimmer, Inc.201502
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+3K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+3K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+3K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+3K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+3K222309Gamma4 SystemStryker GmbH20220—
+3K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH20201—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217