Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

NJD · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3535

Classification

FDA Product Code: NJD
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3535
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 18

Source

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