Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Aesculap activL Artificial Disc
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Highridge Medical, LLC; 10225 Westmoor Dr.; Westminister, CO 80021
• PMA Number: P120024
• Supplement Number: S011
• Date Received: 12/06/2019
• Decision Date: 01/31/2020
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval forfollowing changes to the activL® Artificial Disc Enhanced Safety Surveillance Survey:1) Section: Pain Management; Question 4: Add N/A checkbox to the column, Using Spike Endplate as now it is possible that a Surgeon implanters experience would exclude the Spike Endplate and only include the Keel Endplate;2) Section: Spike vs. Keel Endplate Design; HeaderRemove For Surgeons Outside the US ONLY as now it is possible that a Surgeon implanter within the U.S. will have the option of the Spike Endplate and Keel Endplate.The following change to the Aesculap activL® Artificial Disc Enhanced Safety Surveillance Study as follows:3) Appendix ARemove previous version of the activL® Artificial Disc Enhanced Safety Surveillance Survey and replaced it with the updated version reflecting the updates detailed above.