# K081353: Synthes (Usa) Tomofix Medial Distal Femur Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 23, 2008 after 70 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.
35 later devices descend from it; 6 cite it directly.
0 of 36 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 TomoFiX Osteotomy System: named in the summary without a submission number
- (no number) Synthes Large Fragment Dynamic Compression Locking System: named in the summary without a submission number
- (no number) Synthes LCP Distal Femur Plates: named in the summary without a submission number

## Most influential descendants
- K141796: Depuy Synthes Tomofix Osteotomy System (2014), 14 descendants of its own
- K113733: Small and Large Fragments Osteosynthesis System Neofix (2012), 11 descendants of its own
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- K193614: FINE Osteotomy around the knee (2020), 4 descendants of its own
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own

## Indications for use
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/K081353
Methodology: https://510kreport.com/methodology