The US Food and Drug Administration (FDA) has granted De Novo authorization to Johnson & Johnson’s OTTAVA Robotic Surgical System, making it the world’s first table-integrated soft tissue robotic system.
The authorization allows the system to be marketed for a range of general surgery procedures, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.
The company plans to begin a phased commercial rollout of the OTTAVA system with select customers in the United States while working in parallel to advance into additional indications and regulatory jurisdictions over time.
A US clinical trial evaluating OTTAVA for inguinal hernia repair is currently underway.
Tim Schmid, executive vice president, worldwide chairman, MedTech, Johnson & Johnson, said, “We are pioneering a new category of surgical robotics with OTTAVA. This is the start of the next era in surgery as we deliver not just a new surgical robotics system, but a catalyst for fundamentally better surgical care that is informed by technology, guided by clinical insight, and delivered with care by Johnson & Johnson.”
According to Johnson & Johnson, OTTAVA has been purpose-built to meet both current and future surgical needs. The system combines a table-integrated robotic architecture with advanced surgical instruments, automation, and an open digital ecosystem to support more digitally enabled, data-driven surgery.
Hani Abouhalka, company group chair, surgery, MedTech, Johnson & Johnson, said, “By opening up the way we think about architecture, data, and the very workflows of surgery itself, we have designed OTTAVA to deliver clinical and economic benefits and support surgeons and hospitals as the future of surgery unfolds.”
Peter Schulam, chief scientific officer, MedTech, Johnson & Johnson, said that although surgical robotics has helped augment surgical skill, the next generation of care must also integrate data and insights across the surgical ecosystem to support surgeon judgement and help improve patient outcomes. “OTTAVA was designed with that connectivity in mind,” he added.
Key features of the OTTAVA system
The robotic arms are integrated into the operating table, reducing the system’s footprint by approximately 30–50% compared with conventional boom- and cart-mounted robotic systems, creating additional space in the operating room.
Four table-integrated robotic arms are coordinated through sophisticated software, enabling automated, pre-defined procedural poses to simplify setup and breakdown. The synchronized motion of the table and arms provides seamless patient repositioning.
The system features a two-in-one needle driver designed to reduce unintended suture cutting and monopolar curved scissors for consistent and complete cuts.
OTTAVA connects to the Polyphonic digital platform, which supports surgical teams throughout the surgical workflow by bringing learning, media, and data-driven insights together to support continuous improvement across the surgical journey.
Johnson & Johnson MedTech received an investigational device exemption (IDE) approval from the US FDA for the OTTAVA Robotic Surgical System in late 2024, allowing the company to begin clinical evaluation of the platform.
In April 2025, the company successfully completed the first procedures in the OTTAVA clinical trial. The inaugural case involved a Roux-en-Y gastric bypass surgery performed by Dr. Erik Wilson, chief of minimally invasive and elective general surgery at UT Health Houston and the study’s lead investigator, at Memorial Hermann-Texas Medical Center.
