# K063414: Modification to: FMP Metal/Metal Acetabular Insert, Models 499-28, 499-34, 499-38

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Dec 12, 2006 after 29 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- 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 no predicate by number.

## Indications for use
Indications for use in total hip replacement include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

Source page: https://510kreport.com/device/K063414
Methodology: https://510kreport.com/methodology