# K200653: AMF Revision TT Cones

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: May 7, 2020 after 56 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: 6 generations back to K982302 (1998). 18 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053340: Trabecular Metal Tibial and Femoral Cone Augments, Zimmer Trabecular (2006) Summary page 5.
- K102896: Trabecular Metal Tibial Cone Augments, Zimmer Trabecular Metal Technology (2010) Summary page 5.
- K103517: Trabecular Metal Femoral Cone Augments, Zimmer Trabecular Metal Technology, Inc. (2011) Summary page 5.
- K143393: Triathlon Tritanium Cone Augments, Stryker Orthopaedics (2015) Summary page 5.

## Most influential descendants
- K240324: EMPOWR Revision Symmetric Knee Cones (2024), 1 descendant of its own
- K251241: EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (2025), 0 descendants of its own
- K234011: AMF TT Cones (2024), 0 descendants of its own

## Indications for use
Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and Treatment of fractures that are unmanageable using other techniques. In patients with preserved and well functioning collateral ligaments, Physica PS components are also for: Absent or not-functioning posterior cruciate ligament; Severe antero-posterior instability of the knee joint AMF Revision 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/K200653
Methodology: https://510kreport.com/methodology