# K180213: Titanium TomoFix Medial High Tibia Plate Anatomical

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Oct 19, 2018 after 267 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 K023941 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023941: Synthes Tomofix Osteotomy System, Synthes (Usa) (2003) Summary page 4.

## Indications for use
The TOMOFIX™ Medial High Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures, and malalignment caused by injury or disease of the medial proximal tibia for the treatment of: - Unicompartmental medial or lateral gonarthrosis with malalignment of the proximal tibia - Idiopathic or posttraumatic varus or valgus deformity of the proximal tibia

Source page: https://510kreport.com/device/K180213
Methodology: https://510kreport.com/methodology