# K974294: Encore Linear Porous Coated Hip

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jan 12, 1998 after 59 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- 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
- K163497: EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt (2017), 0 descendants of its own

## Recalls of this device
- Jun 21, 2016 · Class II · Z-2242-2016: Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

## 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/K974294
Methodology: https://510kreport.com/methodology