Skip to the latest updates
Clintelo — Innovation IQ for PhysiciansClintelo
My Clintelo
Device IQ
FDA De Novo · Johnson & Johnson · Surgery

OTTAVA Robotic Surgical System

The first soft-tissue surgical robot with its arms built into the operating table.

CompareJohnson & Johnson press release
Granted · De Novo

OTTAVA Robotic Surgical System

Johnson & Johnson · Surgery · First table-integrated soft tissue robotic system

Type
Surgical system
FDA route
De Novo classification
Setting
Operating room
Used by
Surgeons and surgical teams
Bottom line for your practice
50s read

Hospitals have a new robotic option for multiple upper abdominal general surgery procedures, with the arms built into the table. The company will launch first with select U.S. customers, and the release reports no clinical outcome data.

What it is
A soft tissue robotic surgical system with four robotic arms integrated into the operating room table. Software coordinates the arms and table, including automated pre-defined procedural poses for setup and synchronized table and arm motion for patient repositioning.
Indicated for
Authorized for multiple 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.
What changes
The company says the table-integrated design occupies 30-50% less space than traditional boom- and cart-mounted systems, based on an evaluation of systems available as of September 2025. The release does not describe a clinical study or comparison group.
Evidence
Performance testingStudy not named in the releaseThe release gives no clinical study result. It cites only company claims documentation, including a footprint evaluation and cutting performance evaluated after 900 cold and 2,460 hot cuts.Accuracy, bench or analytical testing. The source reports no clinical outcome trial, which is common for cleared devices.
Watch for
The release reports no clinical outcomes, contraindications, warnings or adverse events. A U.S. clinical trial in inguinal hernia procedures is ongoing, and that use is not among the authorized procedures listed.
Training
The company says OTTAVA education will support safe adoption and consistent performance through virtual, hands-on and immersive training for new and experienced robotic surgeons.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
De Novo classification. A new type of low-to-moderate-risk device (Class I or II) with no predicate. The FDA reviewed its safety and effectiveness and created a new device type, which later devices can cite as a predicate.

Clinical summary

Authorized for upper-abdominal general surgery, including Roux-en-Y gastric bypass, sleeve gastrectomy, cholecystectomy, fundoplication and hiatal hernia repair. Its four robotic arms are integrated into the operating table rather than mounted on carts, which the company says takes 30 to 50% less floor space. It is a first-generation system in a limited US rollout, and the announcement cites no comparative outcome data.

From the source 10

Johnson & Johnson press release

The Johnson & Johnson press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. New Brunswick, N.J. – July 22, 2026 – Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for the OTTAVA™ Robotic Surgical System, the world’s first table-integrated soft tissue robotic system.

    Backs · Pathway: De Novo; first claim

  2. The system received marketing authorization for multiple procedures in general surgery, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.

    Backs · Authorized procedures

  3. System authorized for use in multiple procedures in general surgery within the upper abdomen

    Backs · Upper abdomen

View all 10 lines

  1. The novel architecture integrates robotic arms into the OR table and occupies 30–50% less space than traditional boom- and cart-mounted systems,

    Backs · 30-50% less space

  2. * Based on an evaluation of systems available as of September 2025

    Backs · Evaluation as of September 2025

  3. Sophisticated software controls coordinate the four table-integrated arms, enabling automated, pre-defined procedural poses to simplify setup and breakdown.

    Backs · Four arms; automated poses

  4. ** Cutting performance was evaluated by observing for deviations or defects after 900 cold and 2,460 hot cuts

    Backs · 900 cold and 2,460 hot cuts

  5. Johnson & Johnson will commercially launch the OTTAVA system with select customers in the U.S., focusing on early customer success while working in parallel to advance into additional indications and regulatory jurisdictions over time.

    Backs · Launch with select customers

  6. A U.S. clinical trial for OTTAVA in inguinal hernia procedures is ongoing.

    Backs · Inguinal hernia trial ongoing

  7. Developed in collaboration with clinicians, educational experts, and surgical societies, OTTAVA education will support safe adoption and consistent performance through virtual, hands-on and immersive training.

    Backs · Training

Questions

Ask about OTTAVA Robotic Surgical System. Answers are built from Clintelo's entries and link to each one's source; nothing you type is stored.

Answers come from Clintelo's entries and cite their sources. Not medical advice. Do not include patient information.

Read next

Search all of Device IQ