# K110176: Axsos Locked Plating 4.0MM Locking Inserts

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Feb 15, 2011 after 25 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050512: Stryker Locked Plating System, Howmedica Osteonics Corp. (2005) Summary page 2.

## Indications for use
The AxSOS Locked Plating System in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The AxSOS Locked Plating System is indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.

Source page: https://510kreport.com/device/K110176
Methodology: https://510kreport.com/methodology