# K120241: Linear Hip Stem, Size 5

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Feb 24, 2012 after 28 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991325 (1999). 2 ancestors in all.
6 later devices descend from it; 2 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)
- K991325: Modification of Encore Linear Porous Coated Hip, Encore Orthopedics, Inc. (1999) Summary page 1.
- K081679: Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05, Encore Medical L.P. (2008) Summary page 1.

## Most influential descendants
- 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
- K223779: EMPOWR™ blade stem (2023), 0 descendants of its own

## Recalls of this device
- Jul 10, 2018 · Class II · Z-1692-2020: The retaining ring on the neck trials has a potential to fail interoperatively.

## Indications for use
The indications for use of the total hip replacement prosthesis include: noninflammatory 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. This stem is to be press-fit.

Source page: https://510kreport.com/device/K120241
Methodology: https://510kreport.com/methodology