FDA Product Code KRR: Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Leading manufacturers include Howmedica Osteonics Corp., Dba Stryker Orthopaedics.
27
Total
27
Cleared
108d
Avg days
1996
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer Devices (Product Code KRR)
27 devices
About Product Code KRR - Regulatory Context
510(k) Submission Activity
27 total 510(k) submissions under product code KRR since 1996, with 27 receiving FDA clearance (average review time: 108 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
KRR devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →