# K112926: Axsos Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Dec 19, 2011 after 77 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: 4 generations back to K981372 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 3.
- K060514: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 1.

## Indications for use
The Stryker AxSOS™ Small Fragment Plating System is intended for internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies in the following: In Adults: * 4mm Waisted Compression Plate - radius, ulna, distal tibia, fibula, distal humerus, clavicle * 4mm Locking Insert * 4mm Locking Screws * 3.5mm Conical Screws * 3mm One Third Tubular Plate - fibula, metatarsals, metacarpals * 4mm Reconstruction Plate - humerus, pelvis In Pediatrics: * 4mm Waisted Compression Plate - radius, ulna, distal tibia, distal humerus, clavicle * 4mm Locking Insert * 4mm Locking Screws * 3.5mm Cortical Screws The Stryker AxSOS™ Basic Fragment Plating System is intended for internal fixation, stabilization and support of long bone fractures as well as bone fixation osteotomnies in the following: In Adults: * 5mm Waisted Compression Plate - Broad -femur, tibia, humerus, pelvis * 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus, pelvis * 5mm Locking Insert * 5mm Locking Screws * 4.5mm Conical Screws * 5mm Reconstruction Plate - femur, tibia, humerus, pelvis In Pediatrics: * 5mm Waisted Compression Plate - Broad -femur, tibia, humerus * 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus * 5mm Locking Insert * 5mm Locking Screws * 4.5mm Cortical Screws

Source page: https://510kreport.com/device/K112926
Methodology: https://510kreport.com/methodology