# K223318: Internal Joint Stabilizer - Elbow

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, Inc.
- Decided: May 10, 2023 after 194 days
- Product code: OZI (Internal Hinged Elbow Fixator)
- 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 K002923 (2000). 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)
- K153208: Internal Joint Stabilizer - Elbow, Skeletal Dynamics, LLC (2015) Summary page 4.

## Indications for use
The Internal Joint Stabilizer- Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

Source page: https://510kreport.com/device/K223318
Methodology: https://510kreport.com/methodology