# K181091: AxSOS 3 Ti

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Oct 11, 2018 after 170 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: 16 generations back to K954385 (1996). 94 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172350: AxSOS 3 Ti, Stryker GmbH (2017) Summary page 4.

## Most influential descendants
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own
- K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (2023), 4 descendants of its own
- 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

## Indications for use
AxSOS 3 Ti is intended for long bone fracture fixation. Indications include: * Diaphyseal, metaphyseal,epiphyseal,extra- and intra-articular fractures * Non-unions and malunions * Normal and osteopenic bone * Osteotomies * Periprosthetic fractures of the femur and proximal tibia. The AxSOS 3 Ti Waisted Compression Plates are also indicated from fracture fixation of: * Periprosthetic fractures * Diaphyseal and metaphyseal areas of long bones in pediatric patients The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.

Source page: https://510kreport.com/device/K181091
Methodology: https://510kreport.com/methodology