LEM Surgical has secured a second U.S. Food and Drug Administration 510(k) clearance for its Dynamis Robotic Surgical System, expanding the capabilities of what the Swiss company calls the world's first surgical humanoid architecture for orthopedic and spine surgery. The clearance, announced on June 23, 2026, adds freehand navigation support, individual vertebra tracking and stabilization, and introduces cervical indications.
A dual-arm humanoid approach to the spine
For more than two decades, hard-tissue robotics has relied on a single robotic arm tethered to a stationary navigation camera. Dynamis breaks from that model with an upper-torso humanoid configuration in which one arm stabilizes and controls a specific vertebral segment while the second arm executes the clinical intervention. The system can independently and continuously track multiple vertebrae at once, enabling simultaneous bilateral workflow and intraoperative quantification of spinal realignment.
"Our second FDA clearance marks a pivotal step forward," said Yossi Bar, CEO of LEM Surgical. "This upper torso humanoid design enables a safer, highly controlled, and predictable environment that is essential for scalability."
Built for hospital adoption
The Dynamis platform consolidates its dual-arm system into a single compact cart that fits partially beneath the surgical table. Unlike traditional closed systems, it supports a wide range of third-party surgical instruments and implants through robotic adjustable end-effectors and a proprietary intraoperative qualification process, which the company says reduces facility adoption friction and optimizes workflow efficiency. LEM Surgical is headquartered in Bern, Switzerland, with U.S. corporate operations and a demonstration suite in Tampa, Florida.
Crowded but growing market
The clearance lands as competition in robotic surgery intensifies. Medtronic recently advanced its Hugo system into general and gynecologic surgery, CMR Surgical brought its Versius Plus robot to U.S. commercial launch, and Intuitive Surgical continues rolling out da Vinci 5 updates. LEM's bet is that a humanoid, multi-arm design tailored to hard tissue can carve out the orthopedic and spine niche where most platforms have focused on soft-tissue procedures.
Reporting based on coverage from BioSpace, Surgical Robotics Technology and LEM Surgical.