# K032169: Carbon Fiber Composite Circular Fixation (Cirfix) Device (Half Ring)

- Pathway: 510(k) (Traditional)
- Applicant: Cyberorthology, Inc.
- Decided: Sep 22, 2003 after 68 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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: 1 generation back to K870961 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962808: Ilizarov External Fixation System, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K870961: Richards External Fixation System, Richards Medical Co., Inc. (1987) Summary page 1.

## Indications for use
Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied.

Source page: https://510kreport.com/device/K032169
Methodology: https://510kreport.com/methodology