# K201364: LINK TrabecuLink Femoral Cones

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Jul 17, 2020 after 56 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K982302 (1998). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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.
- K200113: LINK TrabecuLink Tibial Cones, Waldemar Link GmbH & Co. KG (2020) Summary page 4.

## Indications for use
The LINK TrabecuLink Femoral and Tibial Cones are indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis and joint fractures which disallow an osteosynthetic reconstruction. The LINK TrabecuLink Femoral and Tibial Cones are indicated for the following conditions: - Surgeries which require implantation of a total knee endoprosthesis after severe degeneration or bone loss, traumata, or other pathologies. The device is intended for uncemented use.

Source page: https://510kreport.com/device/K201364
Methodology: https://510kreport.com/methodology