# K992144: Biopro Rimmed Acetabular Compoment

- Pathway: 510(k) (Traditional)
- Applicant: Biologically Oriented Prostheses
- Decided: Sep 22, 1999 after 90 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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. The FDA summary names its predicate without a number.
- (no number) Biomet Healey Flanged Revision Acetabular Shells: named in the summary without a submission number

## Indications for use
Osteoarthritis Rheumatoid arthritis with severe hip pain and limited joint motion. Avascular necrosis Traumatic arthritis Acetabular cavity deformities caused by congenital problems. Revisional surgery after one or more total hip operations. Fixation with bone cement and/or cancellous bone screws.

Source page: https://510kreport.com/device/K992144
Methodology: https://510kreport.com/methodology