Identity
- Trade Name
- TOPS System FDA PMA
- Generic Name
- Prosthesis, posterior spinal elements FDA PMA
Identifiers
- PMA Number
- P220002 FDA PMA
- FDA Product Code
- QWK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The TOPS System is a Class III motion-preserving spinal prosthesis designed for posterior spinal stabilization. It is intended for lumbar spine applications, providing flexible fixation without rigid instrumentation to support patients with degenerative spondylolisthesis and lumbar spinal stenosis.
This device is inserted via pedicle screws and is approved for use in patients aged 35 to 80 with symptomatic degenerative spondylolisthesis up to Grade I, featuring ligamentum flavum thickening or facet joint scarring at levels L3 to L5. Supplied sterile and intended for single-use, the TOPS System is regulated under FDA PMA (P220002) and falls under the product code QWK for orthopedic spinal implants.
Frequently asked questions
What specific spinal conditions is the TOPS System approved to treat, and what age range is it intended for?
The TOPS System is approved for patients aged 35 to 80 with symptomatic degenerative spondylolisthesis up to Grade I, combined with moderate to severe lumbar spinal stenosis. It is also indicated for cases involving thickening of the ligamentum flavum or scarring of the facet joint capsule at lumbar levels L3 to L5. The system is designed as a motion-preserving alternative to rigid fixation for posterior spinal stabilization.
How is the TOPS System implanted, and what type of fixation does it provide?
The TOPS System is inserted via pedicle screws into the lumbar spine to provide posterior stabilization. Unlike rigid fixation devices, it is designed to offer flexible support, preserving spinal motion while addressing degenerative conditions like spondylolisthesis and stenosis.
Is the TOPS System intended for single-use or reusable applications, and how is it supplied?
The TOPS System is supplied sterile and explicitly intended for single-use only. This ensures patient safety and reduces the risk of infection or contamination from repeated sterilization processes.
What regulatory pathway was followed for the TOPS System’s approval, and what product code does it fall under?
The TOPS System was approved through the FDA’s Premarket Approval (PMA) pathway under PMA number P220002. It is classified under product code QWK, which corresponds to orthopedic spinal implants, reflecting its use in posterior spinal stabilization procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P220002 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Premia Spine Ltd
- FDA Applicant
- Premia Spine, Ltd.
Sources (1)
- FDA PMA P220002 24 fields · synced Sep 18, 2026