# K023941: Synthes Tomofix Osteotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 23, 2003 after 58 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 9 cite it directly.
0 of 40 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) Anatomical Locking Plate System: named in the summary without a submission number
- (no number) Synthes Locking Condylar Plates: named in the summary without a submission number
- (no number) Synthes Large Fragment LCP System: named in the summary without a submission number
- (no number) Synthes LCP Proximal Tibia Plate: 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
- K041601: Surfix Knee Osteotomy System (2004), 5 descendants of its own
- K193614: FINE Osteotomy around the knee (2020), 4 descendants of its own

## Recalls of this device
- Oct 9, 2013 · Class II · Z-0473-2014: A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a

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

Source page: https://510kreport.com/device/K023941
Methodology: https://510kreport.com/methodology