# K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System

- 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). 263 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System, Stryker GmbH (2020) Summary page 7.
- K181091: AxSOS 3 Ti, Stryker GmbH (2018) Summary page 7.
- K153379: AxSOS 3Ti, Stryker GmbH (2016) Summary page 7.
- K123964: Axsos 3 TI Locking Plate System, Stryker Trauma AG (2013) Summary page 7.
- K060798: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 7.
- K081284: Variax Distal Fibula Plate, Howmedica Osteonics Corp. (2008) Summary page 7.
- K151879: VariAx 2 One-Third Tubular Plating System, Stryker GmbH (2015) Summary page 7.
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System, Stryker GmbH (2023) Summary page 7.

## Most influential descendants
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own
- K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (2026), 1 descendant of its own
- K261481: Pangea Femur Reconstruction System (2026), 0 descendants of its own
- K242445: Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System (2024), 0 descendants of its own

## Indications for use
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 Fibula Plating System: The Pangea Fibula Plating System is indicated for the internal fixation and stabilization of fibula 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/K231262
Methodology: https://510kreport.com/methodology