# K040258: Synthes Medium External Fixation System-MR Safe

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 23, 2004 after 48 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 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 Medium External Fixation System: named in the summary without a submission number

## Most influential descendants
- K071628: Stryker External Fixation System (2007), 1 descendant of its own
- K172438: ARBOR External Fixation System (2018), 0 descendants of its own
- K122208: External Fixator System (2012), 0 descendants of its own
- K072764: KLS Martin Xternal Fixator (2007), 0 descendants of its own
- K051957: Reprocessed External Fixation Device (2005), 0 descendants of its own

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

Source page: https://510kreport.com/device/K040258
Methodology: https://510kreport.com/methodology