# K150640: RX-FIX Mini Rail External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 1, 2015 after 265 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
Longest line of descent: 3 generations back to K831576 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051017: R-X-Fix External Fixator, R-X-Fix (2005) Summary page 4.

## Indications for use
The Rx-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies. The selection of the appropriate type of fixator is left to the discretion of the surgeon, according to the type of fracture and patient’s anatomy.

Source page: https://510kreport.com/device/K150640
Methodology: https://510kreport.com/methodology