Elevation Spine Secures FDA Clearance for Saber-C® AVIA™

In July 2026, Elevation Spine received FDA 510(k) clearance for Saber-C® AVIA™, a complete anterior cervical fixation system with a porous 3d-printed titanium interbody with both spike and screw fixation options.

Inside the Saber-C® AVIA™’s FDA 510(k) clearance

Elevation Spine announced that the FDA has granted 510(k) Clearance for Saber-C® AVIA™, a zero-profile anterior cervical discectomy and fusion (ACDF) construct. This provides the biomechanical stability historically associated with traditional plating and features an innovative design with a porous, 3D-printed titanium interbody with both spike and screw fixation options.

Charlie Gilbride, CEO of Elevation Spine, highlights their focus on feedback from their dedicated Saber-C surgeon community to shape the product. The system offers a slim, lower-profile workflow and updated instruments for precise spike delivery, along with new low-profile screw inserters. Saber-C AVIA includes both spike and screw instrumentation in one tray, enhancing versatility for ACDF cases by delivering meaningful innovation where it counts most.

The titanium interbody's 55% porosity lattice architecture is engineered to mimic trabecular bone, promoting bone ingrowth, and is available in 6° lordotic and 12° hyperlordotic options with a large central graft window.

Impact on the Healthcare Industry

These new systems definitely make an impact on the healthcare industry by introducing a streamlined, single-tray cervical fusion tool that leverages advanced 3D printing to accelerate bone healing.

These systems enhance bone healing by featuring a 3D-printed titanium implant with a 55% porous lattice structure that mimics real human bone to foster natural bone growth. The new system design provides a slim, lower-profile workflow, with additions and refinements across multiple instruments with both spike and screw instrumentation, providing better patient options and thereby streamlining workflow.

These systems also help to address industry hurdles like lowering bulk and risk by offering sufficient strength of a traditional metal plate without protruding into nearby tissues. This also reduces hospital costs and clutter by offering multiple instruments and fixation options in one kit and cuts down preparation time for the lab, overall simplifying procedures for surgeons during anterior cervical discectomy and fusion operations.

Impact on the Spinal Access Systems Industry

The global spinal access systems market revenue reached USD 6.30 billion in 2025 and is predicted to attain around USD 10.38 billion by 2035 with a CAGR of 6.44%.

According to Precedence Research, this clearance benefits the spinal access systems industry by optimizing operating room workflows and delivering advanced biomechanical stability through a zero-profile design.

This clearance provides industry-enhanced versatility by offering surgeons immediate options during procedures. Improved bone ingrowth and streamlined workflow lower the complexity of anterior cervical discectomy and fusion procedures while maintaining strong fixation and resolving challenges like bulky reduction, instrument clutter, and balancing stability with simplicity.

The spike fixation deploys predictably, the workflow is clean, and 5000 implantations speak for themselves, as the platform crosses the 5,000-implantation threshold and thus foresees the next chapter of the Saber-C system for commercial launch.

Impact on the Spinal Implants and Devices Industry

The global spinal implants and devices market size is calculated at USD 14.95 billion in 2025 and is predicted to increase from USD 15.80 billion in 2026 to approximately USD 25.76 billion by 2035, expanding at a CAGR of 5.59% from 2026 to 2035.

According to Precedence Research, this clearance positively impacts the industry with a zero-profile anterior cervical discectomy and fusion system featuring a 55% porous 3D-printed titanium interbody and combined spike and screw options with significant biomechanical stability and maximum versatility for surgeons handling a broad range of ACDF cases. It also addresses industry limitations like complex inventory, procedural inefficiency, and implant rigidity to better replicate natural bone cellular structure than older ones.

About Elevation Spine

Elevation Spine is a medical device manufacturer based in Monterey, California, with expertise in advanced, minimally invasive spinal fusion implants and integrated-fixation technologies. It improves patient outcomes while supporting surgeons with a high-tech and simplified approach to spinal fusion procedures. Elevation Spine's primary goal is to reduce procedural complexity, optimize operating room efficiency, and significantly cut down on the required surgical implant inventory per case. 

Developer of interbody spinal fusion implants designed to be minimally invasive. The company's medical devices are made with technology and materials leveraging proprietary product designs to access a pre-loaded spike fixation that assists in surgical steps and makes it efficient.