QPP · Class II · 21 CFR 888.3600

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 3 in the prior period

FDA 510(k) Cleared Implantable Post-surgical Kinematic Measurement Knee Device Devices (Product Code QPP)

4 devices
1–4 of 4
Cleared Apr 24, 2024
canturio® se (Canturio Smart Extension)
K234056
Canary Medical USA, LLC
Orthopedic · 124d
Cleared Mar 24, 2023
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
K223803
Canary Medical USA, LLC
Orthopedic · 95d
Cleared Jun 22, 2022
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
K220413
Canary Medical USA, LLC
Orthopedic · 128d
Not Cleared Aug 27, 2021
Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
DEN200064
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 3 in the prior period.

QPP devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →