Charite Artificial Disc

FDA premarket approval P040006 · Prosthesis, intervertebral disc

PMA numberP040006

Approval

Applicant
Depuy Spine, Inc.
Received
February 13, 2004
Decision date
October 26, 2004 (APWD)
Supplements
5, latest February 8, 2011
Product code
MJO – Prosthesis, Intervertebral Disc

Official FDA PMA record

Approval order statement

APPROVAL FOR THE CHARITE ARTIFICIAL DISC. THE DEVICE IS INDICATED FOR SPINAL ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS SHOULD HAVE NO MORE THAN 3 MM OF SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. PATIENTS RECEIVING THE CHARITE ARTIFICIAL DISC SHOULD HAVE FAILED AT LEAST SIX MONTHS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE CHARITE ARTIFICIAL DISC.