# K200398: AxSOS 3 AF System and AxSOS 3 Ti System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Jun 5, 2020 after 108 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: 17 generations back to K954385 (1996). 241 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 251 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163650: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K181091: AxSOS 3 Ti, Stryker GmbH (2018) Summary page 5.
- K024060: Modification to Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2002) Summary page 6.
- K050512: Stryker Locked Plating System, Howmedica Osteonics Corp. (2005) Summary page 6.
- K190586: Monster® Screw System, Paragon 28, Inc. (2019) Summary page 6.

## Most influential descendants
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own
- K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (2023), 4 descendants of its own
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own
- K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (2026), 1 descendant of its own
- K233017: TM Plating System (2023), 1 descendant of its own

## Indications for use
The AxSOS 3 Ankle Fusion System is indicated for arthrodesis of the ankle, which includes tibio-talo-calcaneal, tibio-talar, and tibio-calcaneal arthrodesis, in possible conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus. 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. Screws can also be used for arthrodesis.

Source page: https://510kreport.com/device/K200398
Methodology: https://510kreport.com/methodology