# K153208: Internal Joint Stabilizer - Elbow

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, LLC
- Decided: Dec 31, 2015 after 56 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: 1 generation back to K002923 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002923: Dynamic Joint Distractor II External Fixation System, Howmedica Osteonics Corp. (2000) Summary page 4.

## Most influential descendants
- K231447: Double Internal Joint Stabilizer- Elbow (2023), 0 descendants of its own
- K223318: Internal Joint Stabilizer - Elbow (2023), 0 descendants of its own

## 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/K153208
Methodology: https://510kreport.com/methodology