# K040354: Metal/Metal Hip System

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Nov 4, 2004 after 266 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
Longest line of descent: 1 generation back to K003250 (2001). 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)
- K003250: FMP Metal/Metal Acetabular Insert, Encore Orthopedics, Inc. (2001) Summary page 1.

## 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/K040354
Methodology: https://510kreport.com/methodology