# K971581: Hemisphere Cemented Cup

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jul 18, 1997 after 79 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.
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 Hemisphere™ Cemented Cup is intended for single use with bone cement in primary or revision arthroplasty surgery. Indications include: • Osteoarthritis, rheumatoid arthritis, or other osteoarthroses of the hip joint; • Certain femoral neck fractures; • Idiopathic avascular (osteo) necrosis; • Post-traumatic arthritis; • Benign or malignant bone tumors where sufficient bone is present to seat the prosthesis; • Previously failed implant The Hemisphere™ Cemented Cup is intended for use with the Primaloc™ Cemented Hip (K962448) and Headloc™ CoCr femoral heads (K953977), both manufactured by Ortho Development Corporation, and other commercially available hip prosthesis, which have also received FDA clearance.

Source page: https://510kreport.com/device/K971581
Methodology: https://510kreport.com/methodology