# K051017: R-X-Fix External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: R-X-Fix
- Decided: Jun 29, 2005 after 69 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: 2 generations back to K831576 (1983). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 1.
- K964094: Minifix, Ferguson Medical (1996) Summary page 1.

## Most influential descendants
- K150640: RX-FIX Mini Rail External Fixator (2015), 0 descendants of its own

## Indications for use
The R-X-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.

Source page: https://510kreport.com/device/K051017
Methodology: https://510kreport.com/methodology