Product code QPP

Device name

Implantable Post-Surgical Kinematic Measurement Knee Device

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3600

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset