DeviceClearance

Product code NPJ— Orthopedic

CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM

Classification name
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Total cleared
12
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NPJ under 21 CFR 888.3560, via openFDA

Market context for product code NPJ

FDA has cleared 12 devices under product code NPJ between 2005 and 2015, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NPJ

Adverse events under product code NPJ

product code NPJ
Injury
258
Total
258

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NPJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.