Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
NRA · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NRA
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
OR
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.