# K200075: 3DMetal Diaphyseal Femoral Cones

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 13, 2020 after 59 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K982302 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103517: Trabecular Metal Femoral Cone Augments, Zimmer Trabecular Metal Technology, Inc. (2011) Summary page 4.

## Indications for use
The 3DMetal Femoral Cones are indicated for use with the GMK Revision and GMK Hinge knee systems, as well as the GMK femoral extension stems and offsets. Specific indications are as follows: -Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis. -Post traumatic loss of joint configuration. -Considerable loss of function of the knee joint. -High-grade joint destruction requiring additional stabilization and reconstruction of bone defects. -Primary implantation failure. -Former revision arthroplasty.

Source page: https://510kreport.com/device/K200075
Methodology: https://510kreport.com/methodology