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., Dba Stryker Orthopaedics, Waldemar Link GmbH & Co. KG and Microport Orthopedics, Inc..
List of Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer devices (product code KRO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →