# K994007: Mallory/Head Smooth Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 4, 2000 after 72 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911684 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911684: Biomet Cobalt-Chrome Femoral Components, Biomet, Inc. (1991) Summary page 2.
- K942028: RX90 Femoral Component, Biomet, Inc. (1994) Summary page 2.
- K992903: Color Buffed Cemented Femoral, Biomet, Inc. (1999) Summary page 2.

## Indications for use
The Mallory/ Head Smooth femoral component is indicated for: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Revision procedures where other treatment or devices have failed 5) Treatment of nonunions, which are femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. This device is for use with bone cement.

Source page: https://510kreport.com/device/K994007
Methodology: https://510kreport.com/methodology