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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceACTIVL ARTIFICIAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantHighridge Medical, LLC
10225 Westmoor Dr.
Westminister, CO 80021
PMA NumberP120024
Date Received12/18/2012
Decision Date06/11/2015
Product Code MJO 
Docket Number 15M-2218
Notice Date 07/17/2015
Advisory Committee Orthopedic
Clinical TrialsNCT00589797
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S014 S007 S011 S008 S012 S013  S003 S005 S001 S002 S004 
S009 
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