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Three clearances in the spinal space have caught my eye. Eminent Spine’s device is claimed to be the first 3D-printed pedicle screw system in the world to gain FDA 510(k) clearance. The SiVantage company received clearance for its sacroiliac (SI) joint fusion system and was subsequently acquired by Tenon Medical one month later. Finally, Brainlab is launching mixed reality navigation that allows surgeons to place pedicle screws with vital information directly in their field of view.
Spine Implants
Eminent Spine | 3D Titanium Pedicle Screw System, K241663
Submitted June 2024, granted April 2025
Primary predicate: Eminent Spine Diamondback Spinal System, K100377
FYI: The device is reported to be the first and only FDA-cleared 3D-printed pedicle screw system in the world.
The system features cannulated, fenestrated screws made from 100% 3D-printed titanium with a novel 3D Lattice on the surface of the threads for enhanced fixation. Additional features include self-harvesting cutting flutes that do not displace bone, but rather harvest the bone into the internal matrix of the screw.
Full launch is slated for 4Q25.
SiVantage | SImmetry+ System, K250647
Submitted March 2025, granted July 2025
Primary predicate: Zyga Technology SImmetry Sacroiliac Joint Fusion System, K151818
FYI: The Slmmetry+ System is intended for SI joint fusion for conditions including SI joint disruptions and degenerative sacroiliitis.
Previously, SImmetry technology developer Zyga Technology was sold to RTI Surgical in 2018. The startup SiVantage was established in 2023. In August 2025, Tenon Medical acquired SiVantage in a strategic asset acquisition. This deal integrates SiVantage’s SImmetry and SImmetry+ technologies into Tenon’s offerings, expanding its SI portfolio across multiple approaches to the variable sacro pelvic anatomy.
Publicly available information indicates that alpha clinical review of SImmetry+ will commence in 4Q25.
Robotics/Digital Tech
Brainlab | Spine & Trauma Navigation Instruments, K252562
Submitted August 2025, granted September 2025
FYI: This solution delivers an ergonomic view of the navigation screen and allows surgeons to place pedicle screws with vital information directly in their field of vision.
Spine Mixed Reality Navigation combines the company’s optical navigation with advanced mixed reality. This extended visualization is projected directly in the sterile field, delivering a layer of confidence one step beyond traditional navigation technology.
With real-time visualization of entry and target points, Brainlab Spine Mixed Reality Navigation enables the desired placement of pedicle screws according to the surgeon’s pre- or intraoperative plans, including in MIS cases where target identification can be challenging.
