# K123403: Axsos Proximal Lateral Tibia Long Plates

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Mar 20, 2013 after 135 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 K050512 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.
- K050512: Stryker Locked Plating System, Howmedica Osteonics Corp. (2005) Summary page 2.

## Indications for use
The AxSOS Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.

Source page: https://510kreport.com/device/K123403
Methodology: https://510kreport.com/methodology