510(k) Report

Devices descending from K023267

38 later devices reach T2 Supracondylar Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+1K132005Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20134—
+1K072161Biomet Femoral Locking Nail SystemBiomet Manufacturing Corp2007228
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+2K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+2K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+2K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+2K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+2K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20190—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+2K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.2009627
+2K081230Trauson Intramedullary NailTrauson (Jiangsu) Medical Instrument Co., Ltd.20090—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+3K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+3K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+3K172699Agile NailOrthofix Srl20180—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+4K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.20222—
+4K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp.20190—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—