TOPS System
FDA premarket approval P220002 · decided 2023-06-15
Approval details
- PMA number
- P220002
- Trade name
- TOPS System
- Generic name
- Prosthesis, posterior spinal elements
- Applicant
- Premia Spine, Ltd.
- Date received
- 2022-02-16
- Decision date
- 2023-06-15
- Days to decision
- 484 days
- Decision code
- APPR
- Product code
- QWK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Netanya
- 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 join
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ProMIS Extension Rod System (K232719) | Premia Spine, Ltd. | 2023-11-21 |
| ProMIS™ Fixation System (K231844) | Premia Spine, Ltd. | 2023-07-07 |
| Premia Spine XL Instruments (K191854) | Premia Spine, Ltd. | 2019-10-08 |
| VersaLink™ Fixation System (K182598) | Premia Spine, Ltd. | 2018-11-13 |
| ProMIS™ Fixation System (K170061) | Premia Spine, Ltd. | 2017-02-02 |
| ProMIS Fixation System (K150380) | Premia Spine, Ltd. | 2015-07-17 |