QPP · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3600
Classification
FDA Product Code
QPP
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3600
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
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.