TOPS™ System

FDA premarket approval P220002 · Prosthesis, posterior spinal elements

PMA numberP220002

Approval

Applicant
Premia Spine, Ltd.
Received
February 16, 2022
Decision date
June 15, 2023 (APPR)
Supplements
11, latest September 9, 2026
Product code
QWK – Prosthesis, Posterior Spinal Elements

Official FDA PMA record

Approval order statement

Approval for The TOPS System is a motion-preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The TOPS System is intended to stabilize the spine following a lumbar decompression without rigid fixation.The TOPS System is indicated for patients between 35 and 80 years of age with symptomatic degenerative spondylolisthesis up to Grade I, with moderate to severe lumbar spinal stenosis and either the thickening of the ligamentum flavum and/or of the scarring facet joint capsule at one level from L3 to L5.