510(k) Report

Devices descending from K951740

113 later devices reach Intramedulary Fixation Rod through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+7K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+8K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+8K230512Gamma4 SystemStryker GmbH20230—
+8K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+9K222309Gamma4 SystemStryker GmbH20220—
+10K261481Pangea Femur Reconstruction SystemStryker GmbH20260—