Atlas Spine Receives 510K Clearance for its V3 Guided Segmental Cervical Plating System

JUPITER, FL, September 16, 2019 — Atlas Spine Inc., a spinal implant company based in Jupiter Florida, announced today the FDA 510(k) clearance and imminent launch of the V3 Guided Segmental Plating System. The V3 System marks another addition to the innovative portfolio of Anterior Cervical Discectomy and Fusion (ACDF) technology developed by Atlas Spine.

“Conventional plate/cage constructs or stand-alone interbody devices have been the accepted method of fixation for ACDF procedures, but each comes with its own nuances and potential compromises. The V3 progressive technique combines the best attributes of both methods into one system and eliminate their drawbacks. We designed the V3 system to complement our HiJAK AC, the first and only expandable cervical interbody on the market, launched earlier this year. With the positive clinical results from HiJAK and the interest we are seeing from surgeons regarding the V3 system, we’re confident that the combination of the two will be the next evolution in cervical fixation,” says Matt Baynham, Atlas’ CEO.     

V3 versus Conventional Plating

The V3 segmental approach reduces the amount of dissection and retraction required to perform an ACDF by promoting the use of smaller, less invasive, individual plates for multi-level constructs. Published data has shown this methodology yields greater fusion rates for three and four level constructs when compared to conventional plating [1]. This philosophy promotes load sharing at each level, a key factor in healthy fusion, and avoids the risk of the stress shielding seen in single piece multi-level plates. Combined with the customizable HiJAK interbody that offers adjustable lordosis up to 20 degrees, the V3 system gives the surgeon the opportunity to address each diseased segment individually. “No other system allows for this custom approach to cervical fixation. The surgeon can now tailor the implants to meet their patient’s specific needs and more easily accomplish their surgical objectives,” said Baynham.

The unique V3 guidance system provides surgeons the opportunity to temporarily dock the plate onto the face of the HiJAK device providing ease of use and control during the installation process. The guidance feature eliminates “fiddle” often associated with “chasing” a plate while offering easier alignment for multi-level constructs, and optimized plate length to avoid adjacent level encroachment.

V3 versus Standalone

In comparison to zero profile type stand-alone devices, the V3 system offers increased rigidity by placing the plate on the anterior aspect of the vertebral body [2, 3]. The V3 plate allows an easier to achieve screw angulation avoiding the difficulty associated with angled drivers and the risk of skiving/violating the endplate as often seen with zero profile systems.   The segmental technique has been shown to have greater fusion rates than standalone devices for both single and multi-level constructs [1][4].  

Atlas will be exhibiting at NASS in Chicago this year at booth number 4527. Atlas is actively recruiting distributors to service its innovative product line with nationwide hospital contracts.

References

[1]      F. Richard A. Hynes, MD, Melbourne and F. Devin K. Datta, MD, Melbourne, “Prevention of Pseudoarthrosis in Multilevel ACDF with Individual Level Plate Fixation vs. Single Long Plate,” 2017, p. 2017.

[2]      N. Shimamoto, B. W. Cunningham, A. E. Dmitriev, A. Minami, and P. C. McAfee, “Biomechanical evaluation of stand-alone interbody fusion cages in the cervical spine.,” Spine (Phila. Pa. 1976)., vol. 26, no. 19, pp. 432–436, 2001.

[3]      H. Paik et al., “Do stand-alone interbody spacers with integrated screws provide adequate segmental stability for multilevel cervical arthrodesis?,” Spine J., vol. 14, no. 8, pp. 1740–1747, 2014.

[4]      K. J. Song, C. E. Taghavi, K. B. Lee, J. H. Song, and J. P. Eun, “The efficacy of plate construct augmentation versus cage alone in anterior cervical fusion,” Spine (Phila. Pa. 1976)., vol. 34, no. 26, pp. 2886–2892, 2009.