TOPS System

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The TOPS System (Total Posterior Spine System) is a spinal implant designed to stabilize the lower spine and maintain range of motion following lumbar decompression surgery for spinal stenosis and related conditions. Unlike spinal fusion, which eliminates motion at the treated level, TOPS aims to preserve mobility while providing stability. The device is manufactured by Premia Spine and has received approval for clinical use in the United States by the Food and Drug Administration (FDA) and in the European Union under the CE (Conformité Européenne) marking. [1]

Contents

Design and mechanism

The device consists of two titanium plates connected by a mechanical articulating core. The plates are fixed to the vertebrae using pedicle screws, while the core allows controlled motion in flexion, extension, lateral bending, and axial rotation. This design provides stability against shear forces while permitting physiological movement of the operated segment. [2]

Surgical procedure

TOPS is implanted following a lumbar decompression, in which bone and ligament tissue compressing the spinal nerves are removed. After decompression, the facet joints are excised and replaced with the TOPS implant. The goal is to preserve mobility at the treated level while preventing instability that would otherwise be addressed with spinal fusion.

Clinical indications

TOPS is generally indicated for patients with lumbar spinal stenosis, with or without grade I spondylolisthesis. Higher-grade instability is usually treated with spinal fusion rather than motion-preserving devices. [3] [4]

Regulatory history

The device was evaluated under an investigational device exemption in the United States, where it was compared against transforaminal lumbar interbody fusion. It was later granted FDA Breakthrough Device designation in 2021, [5] [6] followed by full FDA approval in 2023 after demonstrating superiority over fusion in composite clinical success. [7] The TOPS System also holds CE marking, signifying that it meets health, safety, and environmental requirements for sale in the European Economic Area.

Clinical evidence

Randomized controlled trials have compared TOPS to lumbar fusion in patients with lumbar spinal stenosis and grade I degenerative spondylolisthesis. In a large multicenter trial, TOPS demonstrated significantly higher rates of clinical success compared with fusion at two years. [8] An earlier multicenter study reported similar findings, with improved patient-reported outcomes relative to fusion. [9] Long-term follow-up has shown that TOPS preserves near-normal motion and may reduce the risk of adjacent segment degeneration. [10]

Health economics

Economic analyses suggest that TOPS may be cost-effective compared with fusion. These findings are based on improvements in quality of life, faster recovery, and reduced need for reoperation over time. [11]

Limitations and safety

Reported complications are similar to those seen with other spinal implants, including infection, implant failure, and the need for revision surgery. Patient selection is critical, as the device is not indicated for individuals with high-grade spondylolisthesis, severe osteoporosis, or significant spinal deformity. [12]

See also

  1. ↑ "TOPS System – P220002". U.S. Food and Drug Administration. 16 June 2023. Retrieved 29 September 2025.
  2. ↑ Wilke, H J; Schmidt, H; Werner, K; Schmölz, W; Drumm, J (2006). "Biomechanical evaluation of a new total posterior-element replacement system". Spine. 31 (24): 2790–2796. doi:10.1097/01.brs.0000245872.45554.c0. PMID   17108830.
  3. ↑ Nassr, Ahmad; Coric, Domagoj; Pinter, Zachariah W; Sebastian, Arjun S; Freedman, Brett A; Whiting, Donald; Chahlavi, Ali; Pirris, Stephen; Phan, Nicolas; Meyer, Scott A; Tahernia, A David; Sandhu, Faheem; Deutsch, Harel; Potts, Eric A; Cheng, Joseph; Chi, John H; Groff, Michael; Anekstein, Yoram; Steinmetz, Michael P; Welch, William C (2024). "Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial". Journal of Bone & Joint Surgery. 106 (12): 1041–1053. doi:10.2106/JBJS.23.00719. PMC   11593996 . PMID   38713762.
  4. ↑ Coric, Domagoj; Nassr, Ahmad; Kim, Paul K; Welch, William C; Robbins, Stephen; DeLuca, Steven; Whiting, Donald; Chahlavi, Ali; Pirris, Stephen M; Groff, Michael W; Chi, John H; Huang, Jason H; Kent, Roland; Whitmore, Robert G; Meyer, Scott A; Arnold, Paul M; Patel, Ashvin I; Orr, R Douglas; Krishnaney, Ajit; Boltes, Peggy; Anekstein, Yoram; Steinmetz, Michael P (2022). "Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis". Journal of Neurosurgery: Spine. 38 (1): 115–125. doi:10.3171/2022.7.SPINE22536. PMID   36152329.
  5. ↑ Kirsh, D (31 March 2021). "Premia Spine wins FDA breakthrough designation for spinal arthroplasty system". MassDevice. Retrieved 29 September 2025.
  6. ↑ "Premia Spine gets FDA breakthrough device status for TOPS spinal arthroplasty system". NS Medical Devices. 1 April 2021. Retrieved 29 September 2025.
  7. ↑ "TOPS System – P220002". U.S. Food and Drug Administration. 16 June 2023. Retrieved 29 September 2025.
  8. ↑ Nassr, Ahmad; Coric, Domagoj (2024). "Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial". Journal of Bone & Joint Surgery. 106 (12): 1041–1053. doi:10.2106/JBJS.23.00719. PMC   11593996 . PMID   38713762.
  9. ↑ Coric, Domagoj; Nassr, Ahmad (2022). "Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis". Journal of Neurosurgery: Spine. 38 (1): 115–125. doi:10.3171/2022.7.SPINE22536. PMID   36152329.
  10. ↑ Smorgick, Yossi; Mirovsky, Yigal; Floman, Yizhar; Rand, Nahshon; Millgram, Michael; Anekstein, Yoram (2019). "Long-term results for total lumbar facet joint replacement in the management of lumbar degenerative spondylolisthesis". Journal of Neurosurgery: Spine. 31 (5): 711–718. doi:10.3171/2019.7.SPINE19150. PMID   31585417.
  11. ↑ Ament, J D; Hsieh, C; Sun, S X; Utrie, P (2022). "Cost effectiveness of the TOPS System compared to transforaminal lumbar interbody fusion (TLIF) in the treatment of lumbar spinal stenosis with spondylolisthesis: results from the IDE study". Journal of Health Economics and Outcomes Research. 9 (1): 76–83. doi:10.36469/jheor.2022.31747 (inactive 29 September 2025). PMID   35664635.{{cite journal}}: CS1 maint: DOI inactive as of September 2025 (link)
  12. ↑ Fiani, B; Noblett, C; Chacon, D (2020). "Total Posterior Spinal Arthroplasty Systems for Dynamic Stability". Cureus. 12 (12) e12361. doi: 10.7759/cureus.12361 . PMC   7839802 . PMID   33520555.
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