# K982389: Odc B2 Bipolar Cup

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Oct 7, 1998 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is intended for single-use cementless implantation during primary or revision arthroplasty surgery. The bipolar cup allows for primary articulation between the acetabulum and femoral stem to restore patient mobility. Indications for use are: Osteoarthritis, rheumatoid arthritis, or other osteoarthrosis of the hip joint; Certain femoral neck fractures or dislocations; Post-traumatic arthritis; Idiopathic avascular necrosis of the femoral head, Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis; Previously failed surgery The ODC™ B2 Bipolar Cup may be used with the Primaloc™ Cementless Hip System, which is cleared for use under Premarket Notification K953977.

Source page: https://510kreport.com/device/K982389
Methodology: https://510kreport.com/methodology