# K993943: Encore Linear Porous Coated Hip with HA, Encore Foundation Porous Hip with HA, Encore Revelation Porous Hip with HA

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Feb 4, 2000 after 77 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MCS — HA Porous Coated Total Hip (Exactech): named in the summary without a submission number
- (no number) Natural-Hip Porous Stem with HA (Intermedics): named in the summary without a submission number

## Recalls of this device
- Jun 30, 2004 · Not classified · Z-1128-04: Hip stem product was mis-labeled with wrong size.

## 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/K993943
Methodology: https://510kreport.com/methodology