# K070221: FMP Metal/Metal Acetabular Insert, 499-28,449-34, 499-38

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Apr 4, 2007 after 70 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
Joint replacement is indicated for patients suffering from disability due to: * noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; * rheumatoid arthritis; * correction of functional deformity; * femoral fracture; This device may also be indicated in the salvage of previously failed surgical attempts. Joint replacement is indicated for patients suffering from disability due to: * noninflamrmatory degenerative joint disease including dsteoarthritis and avascular necrosis of the natural femoral head; * rheumatoid arthritis; * correction of functional deformity; * femoral fracture; This device may also be indicated in the salvage of previously failed surgical attempts. Joint replacement is indicated for patients suffering from disability due to: * noninflanmmatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; * rheumatoid arthritis; * correction of functional deformity; * femoral fracture; This device may also be indicated in the salvage of previously failed surgical attempts.

Source page: https://510kreport.com/device/K070221
Methodology: https://510kreport.com/methodology