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: April 1, 2021
Approval Letter: Approval Order
What is it?
The Simplify Cervical Artificial Disc is an implant (device) that replaces one or two adjacent discs 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.
The Simplify Cervical Artificial Disc can now stabilize the spine after the removal of one or two adjacent damaged or diseased disc(s). An earlier version of this device was previously approved only for one damaged or diseased disc.
How does it work?
The implant replaces a damaged or diseased disc in the neck. It is intended to relieve pain and allow motion in every direction.
When is it used?
The Simplify® Cervical Artificial Disc is used following removal of one or two adjacent damaged or diseased disc(s) in people who have fully grown and completely developed bones (skeletally mature).
What will it accomplish?
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 people return to normal activities.
In a clinical study of 182 patients, there was an 86.7% overall success rate in pain relief and 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
- Osteoporosis, osteopenia, or bone weakness
- Any known allergy to the implant’s materials (PEEK, ceramic, and titanium)
- Severe disease or degeneration of the facets (small joints behind the spinal disc)
- Bone spurs that form a bridge of bone between 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
- Weak 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):
- Summary of Safety and Effectiveness Data (SSED)
- Patient Labeling
- Physician Labeling
- PMA Database Entry