T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
FDA 510(k)Class II (US FDA 510(k))
by Stryker GmbH
Identifiers
- 510(k) Number
- K253640 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
- Models / Variants
- T2 Alpha Femur Retrograde Nailing System FDA 510(k)Pangea Femur Reconstruction System FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System, which is a substantially equivalent orthopedic device cleared through the FDA 510(k) process. It is designed for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
The system is supplied by Stryker GmbH and is intended for use in treating distal and diaphyseal femoral fractures. It supports hybrid fixation strategies when stability, alignment, and confidence are required, integrating the nail and plates to work together as a cohesive reconstruction solution for complex femur fractures.
Frequently asked questions
What is the T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System used for?
It is designed for the temporary stabilization of bone segments or fragments in distal and diaphyseal femoral fractures until bone consolidation has been achieved, supporting hybrid fixation strategies when stability, alignment, and confidence are required.
How is the T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System supplied?
The system is supplied by Stryker GmbH as a cohesive reconstruction solution integrating the nail and plates to work together for complex femur fractures.
Is the T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System intended for single-use or reuse?
The device is intended for temporary stabilization until bone consolidation, indicating it is designed for single-use during the healing period, though explicit reuse instructions are not provided in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pangea Femur Reconstruction System | Stryker, T2 Alpha Femur Retrograde Nailing System | Stryker, T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction ..., PDF Ileana Freige Selzach, Solothurn, Ch, 2545 System Regulation Number: 21 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253640 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (1)
- FDA 510(k) K253640 24 fields · synced Oct 6, 2026