# K990821: Providence Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Apr 29, 1999 after 49 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
Longest line of descent: 1 generation back to K962769 (1996). 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)
- K962769: Horizon Hip System, Biologically Oriented Prostheses (1996) Summary page 1.
- (no number) Interseal shell: named in the summary without a submission number

## Indications for use
A) Osteoarthritis B) Rheumatoid arthritis with severe hip pain and limited joint motion C) Avascular necrosis D) Traumatic arthritis E) To be used in conjunction with a Biopro femoral stem and a 28mm or 32mm Biopro ceramic or cobalt chrome head.

Source page: https://510kreport.com/device/K990821
Methodology: https://510kreport.com/methodology