This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: activL® Artificial Disc
PMA Applicant: Aesculap Implant Systems, LLC
Address: 3773 Corporate Parkway, Center Valley, PA 18034
Approval Date: June 11, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120024a.pdf
What is it? The activL® Artificial Disc is an implant that replaces the function of a damaged or diseased spinal disc. The activL® consists of two metal (cobalt-chromium with a titanium coating) endplates surrounding a plastic (polyethylene) insert. The endplates attach to the patient’s vertebrae, and the plastic insert fits between them. The insert is designed to move during daily activities.
How does it work? The implanted device replaces a disc in the lumbar spine. It is intended to relieve pain and allow forward and backward motion at the spinal level.
When is it used? The activL® Artificial Disc is indicated for people who have fully formed and fully grown bones (are skeletally mature), have low back pain due to a problem with one lumbar disc (as determined by a doctor), have been diagnosed as having degenerative disc disease (DDD) in only one lumbar disc at either level L4/L5 or L5/S1 (as determined by a doctor), and have gone through at least six months of non-surgical treatment without relief.
What will it accomplish? The device is designed to help stabilize the operated spinal level. Unlike a fusion procedure, the activL® Artificial Disc is designed to allow motion at the operated spinal level, although not all patients will achieve motion after treatment. The device also may lessen back and/or leg pain, and it may help patients return to their normal activities.
When should it not be used? (Contraindications) The activL® Artificial Disc is not for patients who have:
- Active whole body (systemic) infection such as pneumonia or infection near the surgical site, because undergoing surgery could interfere with their ability to heal and could increase the chance of spreading or worsening the infection.
- Osteoporosis or osteopenia (thin or weak bones), because these conditions could increase the risk of your bones breaking or could cause the implant to loosen.
- An allergy or sensitivity to the materials that make up the activL® Artificial Disc implant (cobalt, chromium, polyethylene, titanium, tantalum, and calcium phosphate).
- Leg pain caused by single nerve root compression (“pinched nerve”), because this pain may be treated with a different surgical procedure.
- Narrowing of the spinal canal (stenosis), nerve root damage (chronic radiculopathy), disc fragment that has separated and moved from the disc space, or spinal deformity such as scoliosis because surgery with the activL® Artificial Disc may not be able to treat these symptoms.
- Too much forward slippage of your upper vertebra with respect to your lower vertebra (spondylolisthesis > grade 1) or a fracture (break) in a specific location in your vertebrate (referred to as a pars defect) that could cause instability within your spine.
- A lumbar spine that shows an unhealthy amount of extra movement (instability) on x-rays, because the activL® Artificial Disc may not provide enough stability.
- Damaged lumbar vertebrae due to an accident (trauma) or disease (including inflammatory diseases where the vertebrae swell or grow together and limit movement such as ankylosing spondylitis and rheumatoid arthritis). Use of the activL® Artificial Disc in these situations may lead to poor performance of the implant.
- Severe disease or degeneration in the joints in the back of spine (facet joints), because surgery with the activL® Artificial Disc will not treat this.
- Too little space remaining between the vertebrae because the disc has collapsed too much. In these cases, the activL® Artificial Disc will not be able to function properly.
- Disc degeneration requiring treatment at more than one level.
- Existing conditions that would make surgery through the belly impossible.
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.