# K100676: Synthes Tomofix (TM) Meial High Tibia Plate, Small

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Apr 8, 2010 after 29 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes (USA) TomoFix Osteotomy System: named in the summary without a submission number

## Most influential descendants
- K212545: FlexitSystem Knee osteotomy system (2022), 0 descendants of its own

## Indications for use
The Synthes TomoFiXTM Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

Source page: https://510kreport.com/device/K100676
Methodology: https://510kreport.com/methodology