Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

NPJ · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3560

Classification

FDA Product Code: NPJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3560
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.

Market data

Cleared 510(k) submissions: 12
Registered establishments: 70

Source

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