Spinal Tech

Spinal Simplicity earned the FDA’s 510(k) clearance for the Freedom decompression system, according to an April 23 news release. The minimally invasive system is designed for lumbar spinal stenosis and introduces enhanced instrumentation to improve procedural precision and efficiency. “Freedom…

Foundation Surgical’s NavLock lateral lumbar disc prep instruments earned the FDA’s 510(k) clearance for use with Medtronic’s O-arm and StealthStation, according to an April 16 LinkedIn post. The NavLock system offers real-time navigation for every step of discectomy, and Foundation…

CarboFix’s CarboClear hybrid posterior screw system earned 510(k) clearance from the FDA. The system is cleared for use across indications including oncology, degenerative conditions, trauma, revision surgery and infections, according to an April 14 news release shared with Becker’s. It…

Aclarion earned a U.S. patent supporting its AI spine diagnostic tool, according to an April 16 news release. U.S. Patent #12,601,803, is titled “System for Machine Learning-Based Model Training and Prediction for Evaluation of Pain” and covers the company’s machine…

SurGenTec’s TiLink_L navigational instruments earned the FDA’s 510(k) clearance, according to an April 15 news release. The TiLink-L navigation instruments are designed to use with the TiLink SI joint fusion system. They’re also compatible with Medtronic’s StealthStation platform. “The TiLink…

VB Spine completed its acquisition of Augmedics’ xvision spine system, according to an April 13 news release. The deal was first announced in February and is expected to poise VB Spine to become a leader in AR-enabled spine tech. “We…

BoxSpine earned FDA clearance for its Duet spinal fixation system, according to an Aug. 9 news release. Duet is a three-piece stabilization system designed to eliminate the need for traditional rods. The design has a halo device that captures a…

Highridge Medical and Waypoint Orthopedics have partnered to distribute the Waypoint GPS system for pedicle screw placement, according to an April 9 news release. The Waypoint GPS is a disposable single-use pedicle probe that uses color-sensing technology to identify the…

Orthofix has eliminated the president of global spine solutions as part of realignment efforts, the company said April 9. Key spine leaders will now report directly to Orthofix CEO Massimo Calafiore, according to a news release. The realignment is designed…

Since March 25, there have been two key developments in lawsuits involving spine medtech companies. 1. The U.S. Court of Appeals for the Ninth Circuit ruled that Medtronic can’t be sued by a man who alleged the company’s spinal cord…