# K012019: Color Buffed (CB) DDH Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jul 20, 2001 after 22 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 K992903 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992903: Color Buffed Cemented Femoral, Biomet, Inc. (1999) Summary page 1.

## Indications for use
The CB DDH Femoral Stem is intended for noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheurnatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and revisions of hip replacement components.

Source page: https://510kreport.com/device/K012019
Methodology: https://510kreport.com/methodology