# K122636: Revelation Porous Coated Hip Stem, Size 8

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Nov 2, 2012 after 65 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
Longest line of descent: 1 generation back to K994070 (2000). 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)
- K994070: Revelation Porous Hip Stem, Encore Orthopedics, Inc. (2000) Summary page 2.
- K081679: Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05, Encore Medical L.P. (2008) Summary page 2.

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head rheumatoid arthritis correction of fuinctional deformity femoral fracture This device may also be indicated in the salvage of previously failed surgical attempts The constrained acetabular component is indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for who all other options to constrained acetabular components have been considered. The device is intended for cementless applications.

Source page: https://510kreport.com/device/K122636
Methodology: https://510kreport.com/methodology