Activl Artificial Disc

FDA premarket approval P120024 · Prosthesis, intervertebral disc

PMA numberP120024

Approval

Applicant
Highridge Medical, LLC
Received
December 18, 2012
Decision date
June 11, 2015 (APPR)
Supplements
12, latest January 29, 2026
Product code
MJO – Prosthesis, Intervertebral Disc

Official FDA PMA record

Approval order statement

APPROVAL FOR THE ACTIVL® ARTIFICIAL DISC. THIS DEVICE IS INDICATED FOR RECONSTRUCTION OF THE DISC AT ONE LEVEL (L4-L5 OR L5-S1) FOLLOWING SINGLE-LEVEL DISCECTOMY IN SKELETALLY MATURE PATIENTS WITH SYMPTOMATIC DEGENERATIVE DISC DISEASE (DDD) WITH NO MORE THAN GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, PHYSICAL EXAMINATION, AND RADIOGRAPHIC STUDIES. THE ACTIVL® ARTIFICIAL DISC IS IMPLANTED USING AN ANTERIOR RETROPERITONEAL APPROACH. PATIENTS RECEIVING THE ACTIVL® ARTIFICIAL DISC SHOULD HAVE FAILED AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE DEVICE.