LEM Surgical

Company overview

LEM Surgical develops and manufactures robotic systems for hard tissue surgery in Bern, Switzerland. Its flagship Dynamis platform combines two robotic guidance arms and a third arm for optical navigation on a single cart positioned partly beneath the surgical table.

Dynamis supports navigation and guidance of qualified instruments during spine procedures. The system uses CT-derived imaging, planning software and real-time tracking; its FDA-cleared indications include placement of spinal pedicle screws. Compatibility depends on instrument qualification and the applicable labeling.

Founded in 2021, LEM is led by CEO Yossi Bar, CCO Chris Prentice and CFO Olaf Reich. The company reports that Dynamis is in clinical use and available for sale in the United States, with U.S. offices and a demonstration suite in Tampa, Florida.

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Products & regulatory status How does MedTechIndex get this information?

Summary

Dynamis has two documented FDA 510(k) clearances: K243326 (April 23, 2025) and K260369 (June 20, 2026). LEM Surgical AG is the applicant. The system assists anatomical localization and instrument guidance in open or percutaneous spine procedures, with indications for spinal pedicle screw placement. ^[10][11][8]

The 2026 decision extends the existing platform with expanded freehand navigation, individual vertebra tracking, stabilization workflows and cervical indications. These clearances cover the described navigation and robotic guidance functions; they do not establish authorization for autonomous surgery or every proposed hard tissue application. ^[8]

No matching recall events were identified in the FDA recall and enforcement datasets searched under LEM Surgical and Dynamis Robotic names. ^[12]

Regulatory snapshot How to read this snapshot

U.S. FDA

2

510(k) clearances

—

De Novo grants

0

PMA approvals

0

Recall events

Latest recorded source review: 2026-10-22.

Commercial portfolio snapshot

Documented commercial product families.

Robotic spine surgery and navigation system

Dynamis Robotic Surgical System ↗

Integrated multi-arm robotic platform combining two instrument-guidance arms, an optical navigation camera arm and CT-based planning and tracking software. ^[5][7][8]

FDA-cleared

Company reports clinical use and commercial availability in the United States.