# K914558: Traumafix (TM) External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 16, 1992 after 93 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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.
29 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960297: Mandibular Bone Distractor II (1996), 23 descendants of its own
- K964649: Vazquez Diner Intraoral Distraction Device (1997), 17 descendants of its own
- K972166: Guerrero - Bell Distractor (1997), 11 descendants of its own
- K972154: Cohen Distractor (1997), 8 descendants of its own
- K990944: Osteomed Intraoral Distraction System (1999), 7 descendants of its own

Source page: https://510kreport.com/device/K914558
Methodology: https://510kreport.com/methodology