# K082398: Encore Hip Stems with Ceramic Heads and Uhmwpe Liners

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Oct 15, 2008 after 56 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
Longest line of descent: 2 generations back to K930963 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955563: Foundation Forged, Textured & Porous Stems W/Biolox Ceramic Heads, Encore Orthopedics, Inc. (1996) Summary page 1.

## Indications for use
Total and partial hip 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. The Vitality and Keystone are designed for a cementless application while the Alfa II, R120, and R12OPC are designed for either cemented or cementless applications.

Source page: https://510kreport.com/device/K082398
Methodology: https://510kreport.com/methodology