# K022094: Par 5 Acetabular Component with & Without Hydroxyapatite Coating

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jul 25, 2002 after 28 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 K000254 (2000). 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)
- K000254: Par 5 Acetabular Component, Biomet, Inc. (2000)

## Indications for use
The indications for the PAR 5 Acetabular component are as follows: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 5) Revision procedures where other treatment or devices have failed

Source page: https://510kreport.com/device/K022094
Methodology: https://510kreport.com/methodology