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: Simplify® Cervical Artificial Disc
PMA Applicant: Simplify Medical, Inc.
Address: 685 North Pastoria Avenue, Sunnyvale, CA 94085
Approval Date: September 18, 2020
Approval Letter: Approval Order

What is it? The Simplify Cervical Artificial Disc is an implant (device) that replaces a single disc between the vertebrae, or bones, of the neck (cervical spine areas C3 to C7). The implant is made of two plastic endplates and a ceramic core. Each endplate is coated with titanium, which helps bone grow onto the endplates, attaching them to the vertebrae located above and below the implant.

How does it work? The implant replaces a diseased or damaged disc in the neck. It is intended to relieve pain and allow movement in every direction.

When is it used? The Simplify Cervical Artificial Disc is used following removal of a damaged or diseased disc in patients who have fully grown and completely developed bones (skeletally mature).

What will it accomplish? The Simplify Cervical Artificial Disc is designed to stabilize the spine after the removal of a damaged or diseased disc. Unlike a spinal fusion procedure, this implant allows for more movement in the neck, although not every patient who receives this implant will achieve a full range of motion after surgery. The implant may also reduce neck and/or arm pain and it may help patients return to normal activities.

In a clinical study of 150 patients, there was a 93.0% overall success rate in pain reliefand restoration of function for the Simplify Cervical Artificial Disc two years after surgery.

When should it not be used? The Simplify Cervical Artificial Disc should not be used in patients with:

• An active infection in the body or at the location on the body where surgery will take place
• Degenerative disc issues that require surgery at more than one spinal location
• Osteoporosis, osteopenia, or bone weakness
• Any known allergy to the implant's materials (PEEK, ceramic, and titanium)
• Severe breakdown of the cartilage between the vertebrae, known as facet disease or facet degeneration
• Bone spurs that form a bridge of bone connecting vertebrae in the spine
• X-rays showing that the area of the spine at the neck is not stable enough
• An unnatural shape (deformity) of the neck at the surgery site
• Weakness in the neck bones at the surgery site due to current or past trauma
• Diseases that may affect the spine such as rheumatoid arthritis or ankylosing spondylitis

Additional information (including warnings, precautions, and adverse events):

• PMA Database Entry
• Summary of Safety and Effectiveness
• Patient Labeling
• Physician Labeling