Da Vinci Alternatives: Ottava, Hugo, Versius and Dexter Compared

1 hour ago

3 min read

Da Vinci Alternatives: Ottava, Hugo, Versius and Dexter Compared

The da Vinci is the platform most new soft tissue robots are compared against.

Ottava, Hugo, Versius, and Dexter each hold FDA authorization or clearance, and they reached it by different routes.

Those routes matter because they set what each system is actually allowed to do.

What Authorized and Cleared Mean Here

A 510(k) clearance means the FDA found a device substantially equivalent to one already on the market.

A De Novo authorization creates a new device category when no such comparison device exists.

Ottava, Versius, and Dexter each began with a De Novo authorization, while Hugo and Versius Plus were cleared through 510(k).

Neither route ranks clinical performance, because each decision covers only the procedures named on the label.

The difference is explained further in FDA Cleared vs FDA Approved: What’s the Difference?

Ottava (Johnson & Johnson)

The FDA granted Ottava De Novo authorization on July 22, 2026.

Johnson & Johnson describes it as the first table-integrated soft tissue robotic system, which is a design claim made by the company.

The authorization covers general surgery procedures in the upper abdomen, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair.

Johnson & Johnson announced on January 7, 2026, that a second US clinical trial in inguinal hernia procedures had been approved.

Hugo (Medtronic)

The FDA cleared Hugo on December 3, 2025.

The clearance covers urologic procedures, including prostatectomy, nephrectomy, and cystectomy.

Medtronic reports that its Expand URO clinical study met its primary safety and effectiveness endpoints, which is a company statement.

Medtronic has said that general surgery and gynecologic indications are expected to follow, and neither is part of the current clearance.

Versius and Versius Plus (CMR Surgical)

The FDA granted Versius De Novo marketing authorization in October 2024 for cholecystectomy in adults.

CMR Surgical states that Versius was the first multi-port, soft tissue general surgical robot authorized through the De Novo process.

CMR Surgical announced on December 16, 2025, that its second-generation Versius Plus received 510(k) clearance for cholecystectomy.

CMR reports more than 40,000 procedures completed outside the United States, which is a company figure.

Dexter (Distalmotion)

The FDA granted Dexter De Novo authorization on October 28, 2024 for adult inguinal hernia repair.

Distalmotion positions Dexter for outpatient departments and ambulatory surgery centers, where it says more than 90 percent of US inguinal hernia repairs take place.

Its authorized indication is narrower than Ottava’s, which makes the label the first thing to check.

The Authorizations at a Glance

System	Manufacturer	Regulatory pathway	Authorization date	Authorized indication
Ottava	Johnson & Johnson	De Novo	July 22, 2026	Upper abdominal general surgery (10 listed procedures)
Hugo	Medtronic	510(k)	December 3, 2025	Prostatectomy, nephrectomy, cystectomy
Versius	CMR Surgical	De Novo	October 2024	Cholecystectomy in adults
Versius Plus	CMR Surgical	510(k)	December 16, 2025 (announced)	Cholecystectomy
Dexter	Distalmotion	De Novo	October 28, 2024	Adult inguinal hernia repair

What to Check Before Comparing

A hospital should first match the cleared procedures to its own case mix.

A system cleared for onfree surgical robotics and AI database tracks the sourced claims behind each system; statements about study results and procedure counts are not FDA findings.

The sourced claims behind each system are tracked in the free surgical robotics and AI database.

See every FDA-cleared surgical robot and AI system in one list.

The 2026 Surgical Technology Intelligence Report covers these regulatory milestones in more depth.