# K121024: Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous Press Fit Stem, Size 8;

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jun 19, 2012 after 76 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: 3 generations back to K952191 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991226: Foundation Porous Hip Stem, Encore Orthopedics, Inc. (1999) Summary page 1.
- K952191: Forged Cemented Stem, Encore Orthopedics, Inc. (1995) Summary page 1.
- K991227: 8MM Forged Cemented Stem, Encore Orthopedics, Inc. (1999) Summary page 1.
- K961890: Foundation 9MM Forged Cemented Stem, Encore Orthopedics, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K990135: Trilogy Acetabular System Longevity Crosslinked Polyethylene, Zimmer, Inc. (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K990070: Revelation Hip Stem, Size 8. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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. This stem is intended to be used in a cementless mode. Joint replacement is indicated for patients suffering from disability due to: o noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; * rheumatoid arthritis; o correction of functional deformity; * femoral fracture; This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cementless mode. 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. This stem is intended to be used in a cementless mode. 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. This stem is intended to be used in a cemented mode. 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 fuinctional deformity; * femoral fracture; This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cemented mode. 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 fictional deformity; " femoral fracture; This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cemented mode.

Source page: https://510kreport.com/device/K121024
Methodology: https://510kreport.com/methodology