# K141796: Depuy Synthes Tomofix Osteotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Aug 29, 2014 after 57 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: 1 generation back to K000682 (2000). 3 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081353: Synthes (Usa) Tomofix Medial Distal Femur Plates, Synthes (Usa) (2008) Summary page 4.
- K023941: Synthes Tomofix Osteotomy System, Synthes (Usa) (2003) Summary page 4.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.

## Most influential descendants
- K180310: DePuy Synthes Trauma Orthopedic Plates and Screws (2018), 4 descendants of its own
- K241356: Fine Osteotomy™ (2024), 3 descendants of its own
- K250923: Fine Osteotomy™ (2025), 1 descendant of its own
- K243995: Arthrex Humeral Plating System and Cerclage Button (2025), 1 descendant of its own
- K190391: TDM Plate and Screw Systems (2019), 1 descendant of its own

## Indications for use
The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia. Specifically, - The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia - The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the lateral proximal tibia - The TOMOFIX Lateral Distal Femur Plates are indicated for open-and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur - The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur

Source page: https://510kreport.com/device/K141796
Methodology: https://510kreport.com/methodology