Class Class II
T2 Alpha Femur Retrograde Nailing System (K250163)
Description
T2 Alpha Femur Retrograde Nailing System by Stryker GmbH, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250163
Clearance Date2025-08-13
Clearance TypeTraditional
Product CodeHSB
Regulation Number888.3020
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250163
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. T2 Alpha Femur Retrograde Nailing System (K250163) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, ... | Stryker GmbH | 2023 |
| K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur An... | Stryker GmbH | 2021 |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePu... | Synthes (USA) Products, LLC | 2020 |
| K160545 | GAP ENDO-EXO MEDULLARY SYSTEM | Pega Medical, Inc. | 2016 |
Trace the full predicate network for K250163
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.