# K994070: Revelation Porous Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jan 20, 2000 after 49 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K122636: Revelation Porous Coated Hip Stem, Size 8 (2012), 0 descendants of its own

## Indications for use
The indications for use of the Revelation™ Porous total hip replacement prosthesis 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/K994070
Methodology: https://510kreport.com/methodology
