Secure-C Artificial Cervical Disc

FDA premarket approval P100003 · Prosthesis, intervertebral disc

PMA numberP100003

Approval

Applicant
Globus Medical, Inc.
Received
January 29, 2010
Decision date
September 28, 2012 (APPR)
Supplements
8, latest June 12, 2023
Product code
MJO – Prosthesis, Intervertebral Disc

Official FDA PMA record

Approval order statement

APPROVAL FOR THE SECURE-C ARTIFICIAL CERVICAL DISC. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OFTHE DISC AT ONE LEVEL FROM C3-C7 FOLLOWING SINGLE- LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVELABNORMALITY LOCALIZED TO THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT AS COMPARED TO ADJACENT LEVELS. THE SECURE-C CERVICAL ARTIFICIAL DISC IS IMPLANTED USING AN ANTERIOR APPROACH. PATIENTS SHOULD HAVE FAILED AT LEAST 6 WEEKS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE SECURE-C CERVICAL ARTIFICIAL DISC.