FDA Product Code KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

Constrained knee designs address the most challenging revision and deformity cases in orthopedic surgery. FDA product code KRO covers constrained cemented femorotibial knee prostheses.

These implants provide mechanical constraint of varus-valgus and rotational motion through a linked hinge or post-cam mechanism, compensating for severe ligamentous insufficiency that cannot be managed with less constrained designs.

KRO devices are Class II medical devices, regulated under 21 CFR 888.3510 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Howmedica Osteonics Corp., Biomet, Inc. and Zimmer, Inc..