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: prodisc L Total Disc Replacement
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Centinel Spine, LLC; 900 Airport Rd., Suite 3b; West Chester, PA 19380
• PMA Number: P050010
• Supplement Number: S020
• Date Received: 10/01/2018
• Decision Date: 04/10/2020
• Product Code: MJO
• Advisory Committee: Orthopedic
• Clinical Trials: NCT00295009
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the prodisc® L Total Disc Replacement. The prodisc® L Total Disc Replacement is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one or two adjacent vertebral level(s) from L3-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 Grade 1 spondylolisthesis at the involved level(s). Patients receiving the prodisc® L Total Disc Replacement should have failed at least six months of conservative treatment prior to implantation of the prodisc® L Total Disc Replacement.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2