# K981451: Argomedical Bipolar System

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Aug 21, 1998 after 121 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080647: Accin Bipolar Head System (2008), 0 descendants of its own

## Indications for use
1. Fractures of the proximal femur. 2. Non-unions of proximal femoral neck fractures. 3. Aseptic necrosis of the femoral head. 4. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum. 5. Salvage of failed total hip arthroplasty.

Source page: https://510kreport.com/device/K981451
Methodology: https://510kreport.com/methodology