# K081679: Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Aug 20, 2008 after 64 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K073685: Ota Collagen Biomaterial, Osseous Technologies of America (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K074894: Linear® Hip Stem. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K120241: Linear Hip Stem, Size 5 (2012), 6 descendants of its own
- K130099: Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019 (2013), 4 descendants of its own
- K223103: BethaLoc® stem cementless HA (2023), 1 descendant of its own
- K161610: EXPRT Revision Hip System (2016), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## 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 These devices may also be indicated in the salvage of previously failed surgical attempts. Both the Revelation and Linear hip stems are designed for a cementless application.

Source page: https://510kreport.com/device/K081679
Methodology: https://510kreport.com/methodology