# K162439: AxSOS 3 Ti; Stryker Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Feb 3, 2017 after 156 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: 14 generations back to K954385 (1996). 88 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153379: AxSOS 3Ti, Stryker GmbH (2016) Summary page 5.
- K060798: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 5.

## Most influential descendants
- 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
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 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. SPS Small Fragment Set The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: * One third tubular plate: fibula, metatarsals, metacarpals * Fibular plate: fibula » Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle * Oblique T-plate: distal radius * T-plate: distal radius, calcaneus, lateral clavicle * Cloverleaf plate: proximal humerus, distal tibia * Calcaneal plate: calcaneus * Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.

Source page: https://510kreport.com/device/K162439
Methodology: https://510kreport.com/methodology