KORTHOS / ECOSYSTEM / PRODUCT

OTTAVA Robotic Surgical System

About

About OTTAVA Robotic Surgical System

OTTAVA is Johnson & Johnson MedTech’s table-integrated robotic system for soft-tissue surgery. Four robotic arms are built into the operating table, and the control software coordinates arm placement with synchronized table motion. This architecture is intended to reduce setup clutter and keep the system integrated with routine operating-room workflow.

The platform combines J&J surgical instruments with Polyphonic, a secure digital layer for learning, media and case insights. In July 2026, the system received US FDA De Novo marketing authorization for multiple upper-abdominal general-surgery procedures, including gastric bypass, gastrectomy, cholecystectomy, splenectomy, sleeve gastrectomy, small-bowel resection and hiatal-hernia repair. Its pivotal study completed 30 robotic gastric-bypass procedures without conversion to a non-robotic approach.

Capabilities

Source-backed capabilities

  • Workflows: Surgical robot platform
  • Target markets: Medical robotics domain
  • Robot-assisted surgery

    Claimed - 2025-04-14 - The milestone moves OTTAVA from platform development into clinical use evidence for soft-tissue robotic surgery.

    Source

Timeline

  • OTTAVA receives US FDA De Novo authorization

    2026-07-22 - Regulatory - Authorization covers multiple upper-abdominal general-surgery procedures. OTTAVA coordinates four table-integrated robotic arms with synchronized table motion. A 30-patient pivotal gastric-bypass study completed every procedure robotically without conversion.

    Source
  • Johnson & Johnson submits OTTAVA robotic surgical system to FDA

    2026-01-07 - Regulatory - Johnson & Johnson MedTech submitted the OTTAVA robotic surgical system to the U.S. FDA. The submission was supported by data from the system's investigational device exemption study. The event marks a regulatory milestone after first clinical cases were completed in 2025.

    Source
  • Johnson & Johnson MedTech completes first clinical cases with OTTAVA surgical robot

    2025-04-14 - Capability - Johnson & Johnson MedTech completed the first cases in the clinical trial for the OTTAVA robotic surgical system. The first procedure was a Roux-en-Y gastric bypass at Memorial Hermann-Texas Medical Center. The milestone moves OTTAVA from platform development into clinical use evidence for soft-tissue robotic surgery.

    Source
  • Johnson & Johnson receives FDA IDE approval for OTTAVA robotic surgical system

    2024-11-13 - Regulatory - Johnson & Johnson MedTech received FDA investigational device exemption approval for OTTAVA. The approval allowed the company to begin a U.S. clinical trial of the robotic surgical system. The milestone preceded the first completed OTTAVA cases and later FDA submission.

    Source

Context

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