# K234011: AMF TT Cones

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: Jan 18, 2024 after 30 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: 7 generations back to K982302 (1998). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200653: AMF Revision TT Cones, Lima Corporate S.P.A. (2020) Summary page 5.

## Indications for use
AMF TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Source page: https://510kreport.com/device/K234011
Methodology: https://510kreport.com/methodology