# K123964: Axsos 3 TI Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Mar 28, 2013 after 92 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: 2 generations back to K061012 (2006). 6 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061012: Axsos Plus Locking Plate System, Howmedica Osteonics Corp. (2006) Summary page 2.
- K122308: Axsos Distal Lateral Femur TS Long Plates, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2012) Summary page 2.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 2.
- K052390: Synthes LCP Proximal Tibia Plates Line Extension, Synthes (Usa) (2005) Summary page 2.
- K972323: Osteo Bos System, Osteonics Corp. (1997) Summary page 2.
- K012162: Stryker Plating System Basic Fragment Set, Howmedica Osteonics Corp. (2001) Summary page 2.

## Most influential descendants
- K133440: Axsos 3 TI Locking Plate System Line Extension (2013), 12 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K123964
Methodology: https://510kreport.com/methodology