# K080647: Accin Bipolar Head System

- Pathway: 510(k) (Traditional)
- Applicant: Accelerated Innovation, LLC
- Decided: Jul 8, 2008 after 123 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- 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 K981451 (1998). 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)
- K981451: Argomedical Bipolar System, Stelkast Company (1998) Summary page 1.

## Indications for use
The AccinTM Bipolar Head components are intended to be implanted to replace a portion of the hip for: * Fractures of the proximal femur; * Non-unions of proximal femoral neck fractures; * Aseptic necrosis of the femoral head; * Osteo-rheumatoid and post traumatic arthritis of the hip with minimal distortion of the acetabulum; and * Salvage of failed total hip arthroplasty. The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip System components.

Source page: https://510kreport.com/device/K080647
Methodology: https://510kreport.com/methodology