FDA Product Code QPP: Implantable Post-surgical Kinematic Measurement Knee Device
An Implantable Post-surgical Kinematic Measurement Knee Device Is A Device That Provides Objective Kinematic Data After Total Knee Arthroplasty Surgery. The Kinematic Data Provided By The Device Are Used As An Adjunct To Other Physiological Parameter Measurement Tools Utilized During The Course Of Patient Monitoring And Treatment Post-surgery.
Leading manufacturers include Canary Medical USA, LLC and Canary Medical, Inc..
4
Total
3
Cleared
165d
Avg days
2021
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Implantable Post-surgical Kinematic Measurement Knee Device Devices (Product Code QPP)
4 devices
Cleared
Apr 24, 2024
canturio® se (Canturio Smart Extension)
Canary Medical USA, LLC
Orthopedic
124d
Cleared
Mar 24, 2023
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Canary Medical USA, LLC
Orthopedic
95d
Cleared
Jun 22, 2022
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Canary Medical USA, LLC
Orthopedic
128d
Not Cleared
Aug 27, 2021
Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
Canary Medical, Inc.
Orthopedic
312d
About Product Code QPP - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QPP since 2021, with 3 receiving FDA clearance (average review time: 165 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.