FDA approves Johnson & Johnson table-integrated OTTAVA robotic surgery system
The U.S. FDA granted De Novo authorization for Johnson & Johnson’s OTTAVA Robotic Surgical System, the first table-integrated soft tissue robotic platform. The system supports multiple general surgery procedures and features a 30–50% smaller footprint than traditional systems. A clinical study for inguinal hernia procedures is ongoing.
*this image is generated using AI for illustrative purposes only.
The U.S. Food and Drug Administration granted De Novo authorization for Johnson & Johnson’s OTTAVA Robotic Surgical System, marking the regulatory clearance of the world’s first table-integrated soft tissue robotic platform. The marketing clearance encompasses multiple general surgery procedures. Johnson & Johnson will initiate a commercial rollout with select U.S. facilities, prioritizing initial customer success while working to expand regulatory approvals and procedural indications globally.
The authorization covers procedures including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair. An additional U.S. clinical study evaluating the platform for inguinal hernia procedures is currently underway.
Architecture and Space-Saving Design
Built to support modern operating room workflows, OTTAVA incorporates four robotic arms directly into the operating table. The setup reduces the system’s physical footprint by 30% to 50% compared to conventional boom- or cart-mounted robotic systems, giving surgical personnel more space to move, communicate, and deliver care.
Advanced software controls coordinate the table-integrated arms to allow automated procedural setups. A synchronized feature known as Twin motion coordinates table and arm movements simultaneously, enabling patient repositioning and multi-quadrant surgical access without extensive manual adjustments.
Surgical Instruments and Digital Ecosystem
The platform includes updated surgical instrumentation, featuring monopolar curved scissors designed for complete cuts and a specialized two-in-one needle driver engineered to minimize accidental suture damage. To support clinical teams, the system links to the secure Polyphonic digital ecosystem, which consolidates learning materials, media, and data-driven insights.
Additionally, a comprehensive training framework combining virtual, immersive, and hands-on instruction will assist clinicians in adopting the technology safely and effectively. Hani Abouhalka, Company Group Chair, Surgery, MedTech, Johnson & Johnson, emphasized the system's potential to deliver clinical and economic benefits.
How will the OTTAVA system's space-saving design influence hospital purchasing decisions compared to established competitors like Intuitive Surgical?
What is the projected timeline for obtaining regulatory approvals and expanding procedural indications in international markets?
How will the ongoing clinical study for inguinal hernia procedures impact the platform's adoption in general surgery?
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