# K143138: AxSOS 3 Ti Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Dec 22, 2014 after 49 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: 1 generation back to K041860 (2004). 1 ancestor in all.
26 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 4.

## Most influential descendants
- K153379: AxSOS 3Ti (2016), 25 descendants of its own
- K162439: AxSOS 3 Ti; Stryker Plating System (2017), 24 descendants of its own
- K172350: AxSOS 3 Ti (2017), 17 descendants of its own
- K181091: AxSOS 3 Ti (2018), 11 descendants of its own
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own

## Indications for use
The AxSOS 3 Ti Locking Plate System 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

Source page: https://510kreport.com/device/K143138
Methodology: https://510kreport.com/methodology