# K011034: Synthes (Usa) Medium External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 27, 2001 after 83 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Howmedica Hoffmann® II External Fixation System: named in the summary without a submission number

## Most influential descendants
- K101338: Newfix External Fixation System (2011), 0 descendants of its own
- K043113: Tempfix External Fixation System, MR Safe (2005), 0 descendants of its own

## Indications for use
Synthes Medium External Fixation System is intended for the construction of an external fixator frame for the treatment of pediatric and adult fractures.

Source page: https://510kreport.com/device/K011034
Methodology: https://510kreport.com/methodology