# K092419: Axsos Locked Plating System Line Extension of 3MM Locking Inserts

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 1, 2009 after 26 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K060514: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 2.
- K060798: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 2.
- K061012: Axsos Plus Locking Plate System, Howmedica Osteonics Corp. (2006) Summary page 2.

## Indications for use
The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial 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/K092419
Methodology: https://510kreport.com/methodology