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, Microport Orthopedics, Inc. and Depuy Ireland UC.
FDA 510(k) Cleared Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer Devices (Product Code KRO)
About Product Code KRO - Regulatory Context
510(k) Submission Activity
86 total 510(k) submissions under product code KRO since 1979, with 86 receiving FDA clearance (average review time: 121 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under KRO have taken an average of 60 days to reach a decision - down from 124 days historically, suggesting improved FDA processing for this classification.
KRO devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →