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: TOPS System
PMA Applicant: Premia Spine, Ltd.
Address: 7 Giborey Israel Street Ramat Poleg, Netanya, 4250407, Israel
Approval Date: June 15, 2023
Approval Letter: Approval Order
What is it?
The TOPS System is a spinal implant designed to stabilize the lower spine and maintain range of motion after surgery to relieve compressed nerves (lumbar decompression surgery).
How does it work?
The TOPS System is attached to the posterior spine using pedicle screws. Once in place, it supports the weight of the body while allowing relative movement between the device’s endplates. This device can help maintain some movements of the lumbar spine, including axial rotation, lateral bending, flexion, extension, and translation.
When is it used?
The TOPS System is used in people between 35 and 80 years of age with degenerative spondylolisthesis up to Grade I, at one level from L3 to L5. with moderate to severe narrowing of the lower spine (lumbar spinal stenosis) and either the thickening of vertebral ligaments (ligamentum flava) and/or scarring of the capsule surrounding the facet joint(s).
What will it accomplish?
Unlike spinal fusion, the TOPS System is designed to maintain motion in the lumbar spine after spinal decompression surgery. The surgery may also help reduce pain and allow people to return to activities.
In a clinical study of 115 people treated with the TOPS System who reached 24 months of follow-up, there was a 76.7% overall success rate.
When should it not be used?
The TOPS System should not be used for people with:
- A slip, bulge, or rupture of the disc material between the vertebral bones (disc herniation) at the level where surgery will be performed
- A forward slip of the vertebral bones (spondylolisthesis) that is more than mild (more than Grade I)
- Other types of spondylolisthesis besides degenerative spondylolisthesis, such as spondylolisthesis resulting from trauma, prior surgery, or congenital causes
- Back or leg pain that does not involve the nerve roots or is unknown in origin
- Pressure on the spinal cord or nerve roots caused by trauma, prior surgery, disorders of bone metabolism or present from birth
- Allergy or sensitivity to the implant materials
- A sideways slip of vertebral bones or a curvature measured by a Cobb angle of more than 10 degrees
- A body mass index (BMI) greater than 40 (morbid obesity)
- Weak or less dense bone (bone density measurement (T-score) of -2.0 or less)
- Any type of infection
- Pressure on multiple lumbar and sacral nerves resulting in loss of sensation, lower extremity weakness, or bowel or bladder dysfunction (cauda equina syndrome)
Additional information (including warnings, precautions, and adverse events):