# K231257: Pangea Utility Plating System, Pangea Platform

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Aug 18, 2023 after 109 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: 19 generations back to K954385 (1996). 343 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 345 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System, Stryker GmbH (2023) Summary page 5.
- K180500: VariAx 2 System, Stryker GmbH (2018) Summary page 5.
- K191412: VariAx 2 System, VariAx 2 Mini Fragment System, Stryker GmbH (2019) Summary page 5.
- K151879: VariAx 2 One-Third Tubular Plating System, Stryker GmbH (2015) Summary page 5.
- K972323: Osteo Bos System, Osteonics Corp. (1997) Summary page 5.
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System, Stryker GmbH (2020) Summary page 5.
- K202016: Dall-Miles® Cable System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2020) Summary page 5.

## Most influential descendants
- K242445: Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System (2024), 0 descendants of its own

## Indications for use
The Pangea Utility Plating System 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 Utility Plating System 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. 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.

Source page: https://510kreport.com/device/K231257
Methodology: https://510kreport.com/methodology