# K172350: AxSOS 3 Ti

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Dec 15, 2017 after 134 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: 15 generations back to K954385 (1996). 93 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153379: AxSOS 3Ti, Stryker GmbH (2016) Summary page 4.
- K162439: AxSOS 3 Ti; Stryker Plating System, Stryker GmbH (2017) Summary page 4.
- K961283: Dall-Miles Homogenous Vitallium Cable, Howmedica Corp. (1996) Summary page 4.

## Most influential descendants
- K181091: AxSOS 3 Ti (2018), 11 descendants of its own
- 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
- K213591: ANTHEM® Fracture System (2022), 5 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

## 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 for 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/K172350
Methodology: https://510kreport.com/methodology