# K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Apr 27, 2023 after 265 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: 18 generations back to K954385 (1996). 251 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System, Stryker GmbH (2020) Summary page 7.
- K192217: NCB Plating System Distal Femur and Proximal Tibia, Zimmer GmbH (2019) Summary page 7.
- K172262: EVOS Small Fragment Plating System, Smith & Nephew, Inc. (2017) Summary page 7.
- K162439: AxSOS 3 Ti; Stryker Plating System, Stryker GmbH (2017) Summary page 7.

## Most influential descendants
- 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
- K231257: Pangea Utility Plating System, Pangea Platform (2023), 1 descendant of its own

## Indications for use
The PeriPRO™ Femur Plating System is indicated for internal fixation and stabilization of femur fractures and osteotomies in normal and osteopenic bone. This includes: Non-unions, malunions and deformities Fracture in the presence of intramedullary implants, including periprosthetic fractures The Variable Angle Fixation System is indicated for the internal fixation and stabilization of fractures and osteotomies of the femur in normal and osteopenic bone, including: Non-unions, malunions and deformities Periprosthetic fractures 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 4 mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis. Screws can also be used for arthrodesis. 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. 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/K222381
Methodology: https://510kreport.com/methodology