# K141121: Axsos 3 TI Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Jun 20, 2014 after 51 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: 10 generations back to K962616 (1996). 45 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 2.
- K050646: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2005) Summary page 2.
- K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 2.
- K041533: Synthes (Usa) [Synthes} Peri-Prosthetic Screws, Synthes (Usa) (2004) Summary page 2.

## Most influential descendants
- K153379: AxSOS 3Ti (2016), 25 descendants of its own
- 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

## Indications for use
The AxSOS 3 Ti Locking Plate System 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

Source page: https://510kreport.com/device/K141121
Methodology: https://510kreport.com/methodology