# K242445: Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Oct 6, 2024 after 51 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K954385 (1996). 351 ancestors in all.
No later device cites it as a predicate yet.
0 of 352 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231257: Pangea Utility Plating System, Pangea Platform, Stryker GmbH (2023) Summary page 6.
- K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System, Stryker GmbH (2023) Summary page 6.

## Indications for use
Pangea Platform: The Pangea Platform is indicated for the internal fixation and stabilization of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including: * Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures * Non-unions, malunions, and deformities * Periprosthetic fractures The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis and metaphysis in which growth plates have fused or in which growth plates will not be crossed by implants. Pangea Femur Plating System The Pangea Femur Plating 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 Pangea Tibia Plating System The Pangea Tibia Plating System is indicated for the internal fixation and stabilization of tibia 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 Pangea Humerus Plating System The Pangea Humerus Plating System is indicated for the internal fixation and stabilization of humerus 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

Source page: https://510kreport.com/device/K242445
Methodology: https://510kreport.com/methodology