# K133440: Axsos 3 TI Locking Plate System Line Extension

- Pathway: 510(k) (Special)
- Applicant: Stryker Trauma AG
- Decided: Dec 18, 2013 after 36 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K061012 (2006). 7 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123964: Axsos 3 TI Locking Plate System, Stryker Trauma AG (2013) Summary page 1.
- K972323: Osteo Bos System, Osteonics Corp. (1997) Summary page 2.

## Most influential descendants
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own
- K212433: Anthem Fracture System (2021), 7 descendants of its own
- K213591: ANTHEM® Fracture System (2022), 5 descendants of its own

## Indications for use
The AxSOS 3 Ti Locking Plate System Line Extension is intended for long bone fracture fixation. Indications include: Diaphyseal, rnetaphyseal, epiphyseal, extra- and intra-articular fractures Non-unions and malunions Normal and osteopenic bone Osteotomies

Source page: https://510kreport.com/device/K133440
Methodology: https://510kreport.com/methodology