# K080539: Accin Unipolar Head System

- Pathway: 510(k) (Traditional)
- Applicant: Accelerated Innovation, LLC
- Decided: Jun 2, 2008 after 96 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 K952461 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952461: Endo Prosthesis Femoral Head, Stelkast Company (1995) Summary page 1.

## Indications for use
The AccinTM Unipolar Head is intended to be implanted for use in the reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Avascular Necrosis; The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip Stems.

Source page: https://510kreport.com/device/K080539
Methodology: https://510kreport.com/methodology