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Ottava is Johnson & Johnson MedTech's soft-tissue surgical robot and the newest FDA-authorized entrant, granted De Novo marketing authorization on July 22, 2026 for ten general surgery procedures. Its defining feature is architecture: four nine-jointed arms are built directly into the operating table and stow beneath it, which J&J says cuts OR footprint by 30-50% versus boom-and-cart systems. Commercial rollout is just beginning, so availability is limited.
- FDA De Novo authorization on July 22, 2026 covers ten general surgery procedures, ending da Vinci's long US soft-tissue robotic near-monopoly alongside Hugo [source]
- In the pivotal 30-patient bariatric study, Ottava met its primary safety and performance endpoints with all procedures completed robotically, no conversions [source]
- A US IDE clinical trial of Ottava in inguinal hernia procedures is underway [source]
Specifications
| Specification | Value | Confidence | Source |
|---|---|---|---|
| Arms | 4 robotic arms integrated directly into the operating table | verified | jnjmedtech.com (2026-09-01) |
| Architecture | First table-integrated soft-tissue robotic system; arms stow beneath the table when not in use | verified | jnjmedtech.com (2026-09-01) |
| Arm articulation | 9 joints per arm for anatomical access and collision avoidance | reported | medtechdive.com (2026-09-01) |
| OR footprint | 30-50% less space than boom-and-cart systems, per J&J | reported | medtechdive.com (2026-09-01) |
| Setup automation | Push-button movement into predefined procedural arm poses | verified | jnjmedtech.com (2026-09-01) |
| US indications | 10 general surgery procedures including gastric bypass, gastric sleeve, cholecystectomy, appendectomy and hiatal hernia repair | verified | jnj.com (2026-09-01) |
Every spec is cited to its source with a retrieval date. verified = manufacturer-published · reported = reputable press/analyst. Verify with the manufacturer before purchase decisions.
Change timeline
- milestone FDA grants De Novo marketing authorization for ten general surgery procedures [source]
- milestone J&J submits Ottava to FDA for De Novo classification [source]
Our take
Ottava's table-integrated design is the most genuinely different architecture to reach the US market, and J&J can pair it with its Ethicon instruments business. But it launches years behind da Vinci's ecosystem and slightly behind Hugo's US entry, with an initial indication set focused on upper-abdomen general surgery. Hospital buyers should treat 2026-2027 as Ottava's proving period: watch real-world uptime, instrument breadth and how fast indications expand.
Best suited for
- Bariatric surgery (gastric bypass, gastric sleeve)
- Cholecystectomy and hiatal hernia repair
- Other upper-abdomen general surgery procedures within the authorized set
Ottava: common questions
Is the J&J Ottava robot FDA approved?
Yes. The FDA granted De Novo marketing authorization on July 22, 2026 for ten general surgery procedures, following J&J's submission in January 2026.
Can hospitals buy Ottava now?
Rollout is only beginning as of late 2026 and J&J has described a staged launch; pricing and general availability have not been disclosed.
What makes Ottava different from da Vinci?
Ottava's four arms are integrated into the operating table itself rather than mounted on a boom or carts, stowing beneath the table and reportedly saving 30-50% of OR space. Da Vinci counters with a far larger installed base and broader indications.
What procedures is Ottava cleared for?
Ten general surgery procedures, including Roux-en-Y gastric bypass, gastrectomy, gastric sleeve, cholecystectomy, splenectomy, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair.
Did Ottava go through clinical trials?
Yes. A US IDE study begun in late 2024 supported the submission; in the 30-patient pivotal bariatric cohort, Ottava met its primary safety and performance endpoints with no conversions to non-robotic surgery. An inguinal hernia trial is ongoing.
Sources
- Johnson & Johnson — jnj.com, retrieved 2026-09-01
- Johnson & Johnson MedTech — jnjmedtech.com, retrieved 2026-09-01
- Johnson & Johnson — jnj.com, retrieved 2026-09-01
- MedTech Dive — medtechdive.com, retrieved 2026-09-01
- MassDevice — massdevice.com, retrieved 2026-09-01
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