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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears LEM Surgical's Updated Dynamis Spine Robot, Adding Cervical Indications

The second 510(k) for the multi-arm robot drops a non-cervical limit on pedicle screw placement and adds individual vertebra tracking and freehand navigation.

By News DeskJune 23, 20262 min read
Polyaxial pedicle screw system for spinal fixation
A polyaxial spinal pedicle screw system, the type of implant the Dynamis robot helps place. Not made by LEM Surgical. Kaudris, CC BY-SA 3.0, via Wikimedia Commons · CC BY-SA 3.0
FDA cleared510(k) · K260369FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared a modified Dynamis Robotic Surgical System under 510(k) K260369 on June 20, 2026; LEM Surgical announced it on June 23.
  • The earlier clearance, K243326, covered placement of non-cervical spinal pedicle screws; the new one is indicated for spinal pedicle screws without that limit.
  • The 510(k) summary lists bench and cadaver accuracy testing, with robot-guided accuracy of up to 1.5 mm and 2 degrees and freehand navigation accuracy of up to 2 mm and 2 degrees.

The US Food and Drug Administration has granted LEM Surgical a second 510(k) clearance for its Dynamis Robotic Surgical System, adding cervical spine indications, individual vertebra tracking and expanded freehand navigation, the company said in a June 23 release distributed by Newswire.com.

The FDA clearance letter and 510(k) summary for K260369, dated June 20, 2026, name the company's own Dynamis system, cleared under K243326, as the predicate. The device is classified as an orthopedic stereotaxic instrument.

What changed

According to the summary, the modifications include expanded freehand navigation support, individual vertebra tracking using additional bone-mounted markers, stabilization workflow options, the introduction of cervical indications and user interface changes. The predicate was indicated for the placement of non-cervical spinal pedicle screws; the new clearance is indicated for the placement of spinal pedicle screws. The system is intended as an aid for locating anatomical structures and positioning an instrument holder or guide tube in open or percutaneous procedures, provided the required fiducial markers and rigid patient anatomy can be identified on intraoperative CT scans.

Dynamis uses two computer-controlled robotic arms for surgical guidance and a third arm that holds and controls its navigation camera, all integrated into one cart that sits partially beneath the surgical table, the summary states. Vertebra tracking monitors relative motion between vertebrae to keep instruments aligned with vertebra-specific trajectories, and the stabilization workflow gives additional control of vertebral motion during instrumentation.

The summary lists robot-guided trajectory accuracy of up to 1.5 millimeters and 2 degrees, unchanged from the predicate, and freehand navigation accuracy of up to 2 millimeters and 2 degrees. Testing included navigation accuracy verification to ASTM F2554-22, system accuracy validation in cadavers, software, cybersecurity, electrical safety, biocompatibility, sterilization and human factors testing. The summary does not list a clinical study.

Company claims

LEM Surgical, headquartered in Bern, Switzerland, with US operations in Tampa, Florida, describes the design as an "upper torso humanoid" configuration and says it supports a wide range of third-party instruments and implants through adjustable end-effectors.

"Our second FDA clearance marks a pivotal step forward," chief executive Yossi Bar said. He said one arm can stabilize and control a specific spinal segment while the second arm carries out the clinical intervention; the company's claim that this is a first for a surgical robot has not been independently verified. The release did not give pricing or the number of systems in use.

Sources

  1. LEM Surgical Announces second FDA 510(k) Clearance for Next-Generation Humanoid Robotic Surgical System (Newswire.com release), LEM Surgical, June 23, 2026
  2. K260369 clearance letter and 510(k) summary: Dynamis Robotic Surgical System, US Food and Drug Administration, June 20, 2026