# K153379: AxSOS 3Ti

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: May 26, 2016 after 185 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: 13 generations back to K954385 (1996). 86 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141121: Axsos 3 TI Locking Plate System, Stryker Trauma AG (2014) Summary page 4.
- K143138: AxSOS 3 Ti Locking Plate System, Stryker Trauma AG (2014) Summary page 4.
- K113048: Maxlock Extreme System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.
- K122005: Maxlock Extreme System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.
- K132591: Maxlock Extreme System, Orthohelix Surgical Designs, Inc. (2013) Summary page 4.

## Most influential descendants
- K162439: AxSOS 3 Ti; Stryker Plating System (2017), 24 descendants of its own
- K172350: AxSOS 3 Ti (2017), 17 descendants of its own
- K181091: AxSOS 3 Ti (2018), 11 descendants of its own
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own
- K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own

## Indications for use
AxSOS 3 Ti is intended for long bone fracture fixation. Indications include: • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions and malunions • Normal and osteopenic bone • Osteotomies • Periprosthetic fractures of the femur and proximal tibia The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: • Periprosthetic fractures • Diaphyseal and metaphyseal areas of long bones in pediatric patients. The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.

Source page: https://510kreport.com/device/K153379
Methodology: https://510kreport.com/methodology