# K992903: Color Buffed Cemented Femoral

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Sep 17, 1999 after 18 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 its predicate without a number.
- (no number) Answer Femoral Component: named in the summary without a submission number

## Most influential descendants
- K012019: Color Buffed (CB) DDH Femoral Stem (2001), 0 descendants of its own
- K994007: Mallory/Head Smooth Femoral Component (2000), 0 descendants of its own

## Indications for use
The indications for use for Biomet hip replacement prosthesis include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of non-union, femoral neck fracture, and throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) revisions of hip replacement components. Standard surgical and rehabilitative procedures are indicted with this device. This device is for use with bone cement.

Source page: https://510kreport.com/device/K992903
Methodology: https://510kreport.com/methodology