MONTEREY, Calif.--(BUSINESS WIRE)--Elevation Spine today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) Clearance for Saber-C® AVIA™, the newest product line in the Saber platform. Saber-C AVIA is engineered as a zero-profile anterior cervical discectomy and fusion (ACDF) construct with the biomechanical stability historically associated with traditional plating and features a porous 3D-printed titanium interbody with both spike and screw fixation options.
Elevation Spine Receives FDA 510(k) Clearance for Saber-C® AVIA™, A Complete Anterior Cervical Fixation System with a Porous 3D-Printed Titanium Interbody
2 min read Premium comments
FDA 510(k) clearanceanterior cervical discectomy and fusioncervical spine#acdfElevation SpineSaber-C AVIAanterior cervical plate fixation
"Our dedicated Saber-C surgeon community gave us valuable feedback, and those conversations shaped what came next," said Charlie Gilbride, CEO of Elevation Spine. "We focused on purposeful instrumentation, a porous 3D titanium implant supported by preclinical research, and thoughtful refinements that build on the strengths of the original platform. Our size is one of our greatest advantages. We stay close to our surgeon network, move quickly on their feedback, and remain focused on delivering meaningful innovation where it matters most."
The new system design provides a slim, lower-profile workflow, with additions and refinements across multiple instruments. The majority of the core Saber-C spike instruments have been updated for more precise spike delivery, while new Saber-C screw instruments have been added, including a very low-profile screw inserter. Saber-C AVIA ships with both spike and screw instrumentation in a single tray for every case, offering maximum versatility in the operating room. The result is a system that can help support a full range of ACDF cases, all in one kit.
The porous 3D-printed titanium interbody has a 55% porosity lattice architecture engineered to mimic trabecular bone. The porous structure of Saber-C AVIA is associated with bone ingrowth in preclinical data1. The implant is available in 6° lordotic and 12° hyperlordotic options with a large central graft window.
Saber-C AVIA is available immediately for surgical use in the United States.
1. Data on file
About Elevation Spine
Elevation Spine, headquartered in Monterey, CA, is the leading spinal medical device developer of integrated-fixation technologies. The Saber Technology platform integrates zero-profile, anterior cervical plate fixation with interbody support in the cervical spine. Saber systems are designed to simplify surgical workflow while improving patient outcomes.
Contacts
Media Contact: Martin Klazmer | martinklazmer@elevationspine.com
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Elevation Spine secured FDA 510(k) clearance for Saber-C® AVIA™, a new zero-profile ACDF system. This launch expands their Saber platform, integrating 3D-printed titanium interbodies with versatile spike and screw fixation. The company emphasizes rapid surgeon feedback integration and streamlined workflow, aiming to capture market share in the competitive anterior cervical fusion segment by offering a comprehensive, single-kit solution for diverse ACDF cases.
- Elevation Spine leverages surgeon feedback for rapid product development and market responsiveness.
- The system's versatility and single-kit approach aim to optimize operating room efficiency and adoption.
PhD Lens: Clinical and outcomes impact
Saber-C® AVIA™ is a zero-profile anterior cervical discectomy and fusion (ACDF) construct featuring a porous 3D-printed titanium interbody. Its 55% porosity lattice architecture is designed to mimic trabecular bone, with preclinical data supporting bone ingrowth. The system offers both spike and screw fixation options, providing biomechanical stability comparable to traditional plating, and is available in 6° lordotic and 12° hyperlordotic options.
- The implant's 55% porous 3D-printed titanium structure is engineered for bone ingrowth, supported by preclinical data.
- It combines zero-profile design with traditional plating stability, offering versatile spike and screw fixation.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.