# K022423: External Fixation Ring

- Pathway: 510(k) (Traditional)
- Applicant: Rigid FX Orthopedics, Incorporated
- Decided: Sep 17, 2002 after 55 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: 1 generation back to K941048 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000957: Hoffmann II External Fixation System, Howmedica Osteonics Corp. (2000)
- K941048: True/Lok Monolateral/Bilateral Fixator, Applied Osteo Systems, Inc. (1994) Summary page 1.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.

## Indications for use
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.

Source page: https://510kreport.com/device/K022423
Methodology: https://510kreport.com/methodology