# K972961: Stelkast Bipolar System

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Nov 4, 1997 after 85 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 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
- K112019: Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup (2011), 10 descendants of its own
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own
- K172806: Bencox Mirabo Cup System (2017), 4 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/K972961
Methodology: https://510kreport.com/methodology