FDA clearance for a 3D-printed cervical implant, a new dental resin for the Axtra3D Lumia X1, and $9M in AM qualification awards lead today's briefs.
Three stories worth your attention today: a 3D-printed titanium spine implant just cleared FDA review, a dental materials partnership expanded to a second validated resin, and America Makes distributed $9 million across four teams working on metal AM qualification standards.
Elevation Spine wins FDA 510(k) for Saber-C AVIA
Elevation Spine, a California-based spinal implant developer, received FDA 510(k) clearance for its Saber-C AVIA anterior cervical fixation system. The implant uses a porous 3D-printed titanium interbody with 55 percent porosity, designed to mimic trabecular bone structure found in vertebrae and the pelvis. Preclinical data links the porous architecture to bone ingrowth, which is the main goal when you want the implant to fuse with surrounding tissue rather than sit as a foreign object.
The Saber-C AVIA system is a zero-profile construct, meaning it sits flush in the disc space without protruding anteriorly. It offers both spike and screw fixation in a single tray, and comes in 6-degree and 12-degree lordotic angles with a central graft window. The device is available immediately for surgical use in the US.
Axtra3D and KeyPrint add KeySplint Hard Clear for Lumia X1
Axtra3D is broadening its dental materials portfolio with KeySplint Hard Clear, a biocompatible resin developed with KeyPrint of Keystone Industries. This marks the second KeyPrint material validated for the Axtra3D Lumia X1, following KeyModel Ultra. The partnership is also working through validations for KeyGuide, KeyOrtho Model, KeySplint Soft, and KeySplint Soft Clear.
KeySplint Hard Clear is formulated for post-trauma tooth immobilization and retainers. The clear version passed validation on the Lumia X1 specifically; standard Light Violet is available but not yet validated for that printer. The resin resists staining and abrasion, which matters for anything sitting in a mouth all day.
America Makes Delta Qual 2.0 awards $9 million
America Makes and the National Center for Defense Manufacturing and Machining announced the winners of the Delta Qual 2.0 Project Call, funded by the Office of the Under Secretary of War, Manufacturing Technology Office. The program focuses on modernizing additive manufacturing qualification for defense suppliers.
The four winning teams split $9 million across three topics: quantitative measurement-based installation qualification, bracketed qualification for laser powder bed fusion (LPBF), and a Red Team effort. The stated goal is to increase processing parameter flexibility, streamline testing requirements, and strengthen machine installation standards across the defense industrial base.
Separately, America Makes named its new Executive Committee for 2026-2028. The committee includes three government appointees and eight elected members from the membership community, each serving two-year terms. The group meets regularly to align strategy, policy, and advocacy around speeding AM adoption.
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