# K100475: Axsos Locked Plating System Line Extension of 5MM Locking Inserts

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 30, 2010 after 71 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 of the Stryker Locked Plating System is intended for use in long bone fracture fixation. The AxSOS Locking Plates are 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/K100475
Methodology: https://510kreport.com/methodology