Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

NJL · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: NJL
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 bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 36

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown