# K261481: Pangea Femur Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Jun 29, 2026 after 55 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K954385 (1996). 344 ancestors in all.
No later device cites it as a predicate yet.
0 of 345 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System, Stryker GmbH (2026) Summary page 5.
- K202016: Dall-Miles® Cable System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2020) Summary page 5.
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System, Stryker GmbH (2023) Summary page 5.

## Indications for use
The Pangea Femur Reconstruction System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including: • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures. • Non-unions, malunions, and deformities. • Periprosthetic fractures. Additionally, the Trochanter Plates and Trochanter Attachment Plate are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy. When used with the T2 Alpha Femur Retrograde Nailing System, The Pangea Femur Reconstruction System is used for the indications of the T2 Alpha Femur Retrograde Nailing System.

Source page: https://510kreport.com/device/K261481
Methodology: https://510kreport.com/methodology