Johnson & Johnson submits robotic surgical system for De Novo classification
Esme Needham | January 8, 2026 | News story | Research and Development | FDA, Gastrointestinal tract, Johnson & Johnson
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De Novo classification from the US Food and Drug Administration (FDA).
The Ottava system encompasses surgical instrumentation and will, in future, be connected to the Polyphonic digital ecosystem. It is intended to address unmet need for surgeons.The De Novo classification request – De Novo classification is designed for new, low-to-moderate-risk medical devices – centres on an indication for Ottava that covers upper abdomen surgery, including gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.
The submission is based on data from the Ottava Investigational Device Exemption (IDE) study, filed data used to show Ottava’s safety and effectiveness. Initial cases were completed at Memorial Hermann-Texas Medical Centre by Dr Erik Wilson, chief of minimally invasive and elective general surgery at University of Texas Health (UT Health) Houston and lead study investigator.
“The IDE study builds on a significant body of preclinical evidence we have generated demonstrating the impact of the Ottava system, and provides critical clinical evidence on the system performance,” said Peter Schulam, chief scientific officer, MedTech at Johnson & Johnson.
Additionally, Johnson & Johnson received IDE approval in late 2025 for the initiation of a US clinical trial of Ottava in inguinal hernia procedures. This is one of the US’ most commonly-performed surgeries.
Hani Abouhalka, company group chair, Surgery, MedTech at Johnson & Johnson, said: “We have taken learnings from Johnson & Johnson’s 140 years in surgery, our decades of leadership in minimally invasive surgery and the experiences robotic surgeons and hospitals have had over the past 20 years to design a soft tissue robotic system built for the future of surgery.”
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