# K122308: Axsos Distal Lateral Femur TS Long Plates

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Oct 1, 2012 after 61 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 K061012 (2006). 1 ancestor in all.
20 later devices descend from it; 1 cites it directly.
0 of 22 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.

## Most influential descendants
- K123964: Axsos 3 TI Locking Plate System (2013), 19 descendants of its own
- 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

## 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/K122308
Methodology: https://510kreport.com/methodology