Every FDA-cleared surgical robot: the complete verified list
At least 24 surgical robot systems have an FDA clearance on record, from 22 makers, spanning orthopedics, soft-tissue and multiport surgery, spine, neurosurgery, endoluminal and endovascular procedures, and dental. Most cleared through the 510(k) pathway; 2 cleared through De Novo. Every row below is traced to its FDA filing: rows marked DEPLOY VERIFIED carry a filing number corroborated to a primary FDA record; rows marked company-claimed are cleared but the exact filing number is not yet corroborated, and are labeled as such. Intuitive Surgical's da Vinci (cleared in 2000) is the incumbent; Medtronic's Hugo RAS is the most recent, cleared for urology in December 2025. Each maker below links to its verified registry record.
Clearances are sourced from the DEPLOY registry's FDA filing records. How we verify.
FDA-cleared is not the same as broadly cleared
A clearance is only as wide as its cleared indication. Medtronic's Hugo RAS is FDA-cleared, but only for urologic procedures; general surgery and gynecology are not yet cleared in the US. Read the cleared-indication column, not just the word "cleared."
Submitted is not cleared
SS Innovations' SSi Mantra has a 510(k) submitted to the FDA (December 2025) but no clearance yet. The submission is verified; the clearance is absent. The answer to "is the SSi Mantra FDA-cleared?" is not yet.
FDA-cleared surgical robots
Every surgical robot with an FDA 510(k) or De Novo clearance on record, ordered by clearance date (newest first). Each row is traced to its FDA filing. Where the exact filing number is not yet corroborated to a primary FDA record, it reads N/A and the row is marked company-claimed.
| Cleared indication | ||||||
|---|---|---|---|---|---|---|
| DEPLOY VERIFIED | Hugo RAS | Medtronic | 510(k) | K250725 | 2025-12 | Robotic-assisted surgery, urologic procedures only (prostatectomy, nephrectomy, cystectomy). |
| DEPLOY VERIFIED | TMINI Miniature Robotic System | THINK Surgical | 510(k) | K253661 | 2025-12 | Miniature robotic system for total knee arthroplasty; multiple implant clearances (MOBIO, Medacta GMK Sphere). |
| DEPLOY VERIFIED | Dexter | Distalmotion | 510(k) | K251197 | 2025-09 | Soft-tissue surgical robot with wristed instruments. (Original US authorization was a 2024 De Novo.) |
| DEPLOY VERIFIED | NaoTrac S | Brain Navi | 510(k) | K242575 | 2025-05 | Neurosurgical robot for stereotaxic guiding procedures. |
| DEPLOY VERIFIED | Dynamis | LEM Surgical | 510(k) | K243326 | 2025-04 | Navigation-based robotic platform for spine surgery; adds vertebra tracking, stabilization, and cervical indications. |
| DEPLOY VERIFIED | mBOS | Monogram Technologies | 510(k) | K242121 | 2025-03 | Semi-autonomous total-knee-arthroplasty system. |
| DEPLOY VERIFIED | Versius | CMR Surgical | De Novo | DEN230078 | 2024-10 | Portable soft-tissue robotic surgical system for minimal-access surgery. (Versius Plus 510(k) reported 2026.) |
| DEPLOY VERIFIED | Mako Shoulder | Stryker | 510(k) | K242373 | 2024-11 | Reverse shoulder arthroplasty application on the Mako robotic-arm platform. |
| DEPLOY VERIFIED | Mako Spine | Stryker | 510(k) | K241517 | 2024-08 | Non-cervical pedicle-screw placement on the Mako robotic-arm platform. (Mako foundational TGS clearance: K072806, 2008.) |
| DEPLOY VERIFIED | Maestro | Moon Surgical | 510(k) | K240598 | 2024-06 | Collaborative laparoscopic surgery-assistance system. |
| Company-claimed | Symani Surgical System | MMI | 510(k) | N/A | 2024-04 | Robotic microsurgical system for microsurgery. |
| DEPLOY VERIFIED | da Vinci 5 | Intuitive Surgical | 510(k) | K232610 | 2024-03 | Fifth-generation multiport teleoperated surgical system. (Original da Vinci: K990144, 2000. Ion endoluminal: K182188, 2019.) |
| DEPLOY VERIFIED | MIRA | Virtual Incision | De Novo | DEN230025 | 2024-02 | First miniaturized robotic-assisted surgery device; for colectomy procedures. |
| Company-claimed | GenesisX | Stereotaxis | 510(k) | N/A | 2024 | Robotic magnetic navigation system for endovascular procedures. |
| Company-claimed | MedBot ANT-X | MicroPort MedBot | 510(k) | N/A | 2024 | Automatic robotic device (percutaneous/interventional). |
| DEPLOY VERIFIED | Yomi | Neocis | 510(k) | K222750 | 2023-01 | Robot-assisted dental surgery system (dental implant placement). |
| Company-claimed | Epione | Quantum Surgical | 510(k) | N/A | 2022-03 | Robotic system for percutaneous abdominal ablation (cancer treatment). |
| DEPLOY VERIFIED | CIRQ | Brainlab | 510(k) | K210989 | 2021-06 | Robotic alignment system; neurological stereotaxic instrument. |
| DEPLOY VERIFIED | ROSA | Zimmer Biomet | 510(k) | K182964 | 2019-01 | Robotic platform; ROSA Knee (K182964, 2019), plus ONE Brain, Hip, and Shoulder applications. |
| DEPLOY VERIFIED | Mazor X Stealth | Medtronic | 510(k) | K251316 | 2018-11 | Robotic-assisted spinal surgery system. (Original clearance Nov 2018; K251316 is a software enhancement.) |
| Company-claimed | Monarch | Auris Health | 510(k) | N/A | 2018 | Robotic endoscopy platform (bronchoscopy; urology indication). |
| DEPLOY VERIFIED | Senhance | Asensus Surgical | 510(k) | K171120 | 2017-10 | Multi-port laparoscopic surgical system. (Filed as TransEnterix, later renamed Asensus.) |
| Company-claimed | TiRobot | Tinavi Medical Technologies | 510(k) | N/A | 2016 | Orthopedic surgical robot. First Chinese surgical robot to receive FDA clearance. |
| Company-claimed | CORI | Smith+Nephew | 510(k) | N/A | 2020 | Handheld, imageless robotic-assisted knee surgery system; first indicated for robotic-assisted revision knee surgery. |
Submitted, not yet cleared
A filing is in FDA review but no clearance is on record. The submission is verified; the clearance is absent. This is honest-absence: the answer to "is it FDA-cleared?" is not yet.
| Cleared indication | ||||||
|---|---|---|---|---|---|---|
| DEPLOY VERIFIED | SSi Mantra | SS Innovations International | 510(k) | N/A | submitted 2025-12 | 510(k) submitted to FDA Dec 8, 2025 (pivoted from De Novo). Under review; not cleared. |
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Clearances are drawn from the DEPLOY registry's FDA filing records: DEPLOY VERIFIED where the 510(k) or De Novo number is corroborated to a primary FDA record, company-claimed where the clearance is on record but the exact filing number is not yet corroborated, and honest-absence where a system is submitted but not yet cleared. How we verify
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See also: Intuitive Surgical, Medtronic, robot recalls and safety incidents, all answers.
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