# K061012: Axsos Plus Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 19, 2006 after 37 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 8 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker® Locked Plating System: named in the summary without a submission number

## Most influential descendants
- K122308: Axsos Distal Lateral Femur TS Long Plates (2012), 20 descendants of its own
- 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

## Recalls of this device
- Nov 24, 2008 · Not classified · Z-1062-2009: Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.
- Nov 24, 2008 · Not classified · Z-1063-2009: Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.

## Indications for use
The AxSOSTM Plus 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/K061012
Methodology: https://510kreport.com/methodology