Surgical Robotics TechnologyLast updated 17th June 2025
FDA approval means that the U.S. Food and Drug Administration has reviewed the robot’s safety, effectiveness, and performance for specific surgical procedures. Most surgical robots are cleared through the FDA’s 510(k) process, which requires them to be substantially equivalent to an existing approved device. This clearance ensures the robot meets regulatory standards for use in surgery, but it doesn’t guarantee better outcomes or apply to every type of procedure. It means the device can be legally marketed and used for its approved indications.
Surgical Robots
da Vinci Xi® Surgical System – Intuitive
Intuitive’s da Vinci Xi system is designed for versatility and multi-quadrant access during minimally invasive surgeries. It features a rotating overhead boom, modular robotic arms, and advanced imaging capabilities. This setup allows surgeons to easily reach different areas of the abdomen or pelvis without needing to reposition the system.
Approved Surgeries:
- General surgery
- Gynaecology surgery
- Urology surgery
- Thoracic surgery
da Vinci SP® Surgical System – Intuitive
Intuitive’s da Vinci SP (single port) is built for procedures requiring a single small incision. It uses a single robotic arm that houses three flexible instruments and a 3D camera, all inserted through one port. This system excels in surgeries where access is limited and is valued for reducing scarring and improving patient recovery by minimising trauma.
Approved Surgeries:
- Urology procedures
- Transoral otolaryngology
- Colorectal surgery
da Vinci 5™ Surgical System – Intuitive
Intuitive’s da Vinci 5 is the latest generation system. The system is an evolution of the da Vinci Xi, featuring advancements such as haptic feedback, enhanced imaging, and improved ergonomics.
Approved Surgeries:
- Urology procedures
- General surgery
- Gynaecology surgery
- Thoracic surgery
- Colorectal surgery
Anovo™ Surgical System – Momentis Surgical
Momentis Surgical’s Anovo™ Surgical System is designed to assist surgeons in performing transvaginal minimally invasive procedures. It uses robotic arms that closely mimic human hand and wrist movements, allowing for high precision and control in tight anatomical spaces. During surgery, Anovo™ is inserted through a small vaginal incision, eliminating the need for external abdominal cuts.
Approved Surgeries:
- Hysterectomy
- Salpingectomy
- Oophorectomy
SOLOASSIST II System – AKTORmed
AKTORmed’s SOLOASSIST II is a robotic camera holder that helps surgeons control the laparoscopic camera with precision during minimally invasive surgery. Operated via a joystick or voice commands, it provides a stable, vibration-free image without the need for a human assistant.
Approved Surgeries:
- General surgery
- Gynaecology surgery
- Urology surgery
- Thoracic surgery
- Orthopedic surgery
Senhance® Surgical System – Asensus Surgical
Asensus Surgical’s Senhance® Surgical System is a robotic platform designed for minimally invasive surgeries. It features robotic precision 3D imaging and haptic feedback to boost surgeon control, whilst utilising AI and augmented reality for real-time insights and improved surgical results.
Approved Surgeries:
- Urology surgery
- Gynaecology surgery
- General surgery
MIRA™ Surgical System – Virtual Incision
Virtual Incision’s MIRA™ Surgical System is a miniaturised, robotic-assisted platform designed for minimally invasive abdominal surgeries. MIRA is compact and portable, inserted through a single incision directly into the abdomen. It provides surgeons with enhanced precision and control while reducing the need for large, complex equipment
Approved Surgeries:
- Colectomy
Dexter® Robotic Surgery System – Distalmotion
Distalmotion’s Dexter® robotic surgery system is a robotic-assisted system that blends robotic precision with the adaptability of laparoscopy. It allows surgeons to seamlessly switch between robotic and manual operation during a procedure, enhancing both efficiency and surgical flexibility.
Approved Surgeries:
- Inguinal hernia repair
Maestro™ System – Moon Surgical
Moon Surgical’s Maestro™ System is designed to support laparoscopic procedures. It enhances precision and stability by holding and positioning instruments with robotic accuracy, reducing the need for extra assistants. Compact and adaptable, Maestro integrates easily into existing operating rooms, improving workflow and efficiency without the complexity or high cost of larger robotic systems.
Approved Surgeries:
- Cholecystectomy
- Bariatric surgeries, including sleeve gastrectomy
- Hernia repairs
- Colorectal surgeries
- Anti-reflux procedures
- Hysterectomy
- Cystectomy
- Adnexectomy
- Oophorectomy
Dex Device™ Platform – Dex Surgical
Dex Surgical’s Dex Device™ is a robotic-assisted platform for minimally invasive surgeries. It offers precise instrument control, improving accuracy and flexibility. The system reduces the need for large incisions, leading to smaller scars and quicker recovery times.
Approved Surgeries:
- General laparoscopic surgeries
- Gynaecological surgeries
- Urology procedures
MARS® Platform – Levita Magnetics
Levita Magnetics’ MARS® (Magnetic-Assisted Robotic Surgery) Platform uses magnetic technology to assist surgeons during minimally invasive procedures. It combines a robotic arm with a magnetic controller to precisely manipulate surgical instruments inside the patient’s body without the need for multiple incisions. Surgeons control the system from a console, using magnetic coupling to move instruments smoothly, which enhances dexterity and reduces tissue trauma.
Approved Surgeries:
- Laparoscopic cholecystectomy
- Bariatric surgery
- Prostatectomy
Magnetic Surgical System – Levita Magnetics
Levita Magnetics’ Magnetic Surgical System (MSS) uses a detachable magnetic grasper inside the abdomen and an external magnet on the skin to provide dynamic tissue retraction during minimally invasive surgery. After the surgeon places and detaches the grasper tip, the external magnet couples with it, allowing tissue to be lifted and repositioned without extra incisions or fixed trocars. This magnetic approach improves visualization and reduces instrument crowding in the operative field.
Approved Surgeries:
- Laparoscopic cholecystectomy (BMI of 20–34 kg/m²)
- Bariatric surgery
HandX® Robotic Platform – Human Xtensions
Human Xtensions’ HandX® robotic platform translates a surgeon’s hand movements into complex manoeuvres within the patient during minimally invasive surgery. The system features a compact robotic arm that allows surgeons to manipulate surgical instruments with increased dexterity.
Approved Surgeries:
- General surgery
- Gynaecology surgery
- Urology surgery
FreeHand® Robot – FreeHand
FreeHand’s FreeHand® robot is designed to provide a stable and precise image for surgeons during minimally invasive procedures. It allows the surgeon to control the camera’s position using head movements and foot pedals, eliminating the need for a camera-holding assistant.
Approved Surgeries:
- General laparoscopic surgery
- Gynaecology surgery
- Urology surgery
Versius® Surgical System- CMR Surgical
CMR Surgical’s Versius® Surgical System translates the surgeon’s movements into smaller, more precise motions, allowing for minimally invasive operations in hard-to-reach areas. The surgeon can sit or stand at the console, reducing stress and fatigue associated with prolonged surgery.
Approved Surgeries:
- Cholecystectomy
MONARCH™ Platform – Johnson and Johnson
Johnson and Johnson’s MONARCH™ Platform is a robotic-assisted system designed for minimally invasive procedures. It combines a flexible robotic endoscope with advanced imaging and computer-guided navigation, allowing surgeons to precisely access hard-to-reach areas like small lung nodules or the kidney.
Approved Surgeries:
- Biopsy of small peripheral lung nodules
- Lung cancer diagnosis
Galaxy System™ – Noah Medical
Noah Medical’s Galaxy System™ is a robotic-assisted bronchoscopy platform designed to improve the accuracy and efficiency of diagnosing lung nodules. It integrates multiple advanced technologies to help physicians reach and biopsy small, hard-to-access areas within the lungs.
Approved Surgeries:
- Navigational bronchoscopy
- Lung biopsy
- Early detection of lung cancer
Galen ES™ Robotic System – Galen Robotics
Galen Robotics’ Galen ES™ Robotic System combines robotic-assisted surgery with advanced virtual reality and real-time imaging to assist surgeons during minimally invasive procedures.
Approved Surgeries:
- Ear, nose, and throat minimally invasive procedures
Symani® Surgical System – MMI (Medical Microinstruments Inc)
MMI’s (Medical Microinstruments Inc) Symani® Surgical System is designed for microsurgery, particularly in soft tissue procedures like reconnecting tiny blood vessels and lymphatic ducts as small as 0.1 mm.
Approved Surgeries:
- Extremity reconstruction
- Autologous breast reconstruction
- Lymphatic system repair
Mako SmartRobotics™ – Stryker
Stryker’s Mako SmartRobotics™ combines 3D CT-based pre-surgical planning with real-time haptic guidance. This means that, during surgery surgeons can precisely cut bone and place implants.
Approved Surgeries:
- Total knee arthroplasty
- Partial knee arthroplasty
- Total hip arthroplasty
- Revision total hip arthroplasty
- Shoulder arthroplasty
- Spine surgery
Epione® Robot – Quantum Surgical
Quantum Surgical’s Epione® Robot is a minimally invasive, image-guided system. It works by integrating CT and MRI imaging to plan the procedure, then uses robotic guidance to precisely position needles for ablation, even accounting for patient breathing.
Approved Surgeries:
- Liver cancer
- Kidney cancer
- Pancreatic cancer
- Adrenal gland tumours
- Radiofrequency ablation
- Microwave ablation
- Cryoablation
- Irreversible electroporation
MicroMate™ Robotic Platform – Interventional Systems
Interventional Systems’ MicroMate™ is a compact robotic assistant designed for precise needle-based interventions guided by imaging like CT and fluoroscopy. MicroMate™ helps physicians accurately position needles for biopsies and ablations. Compatible with various imaging techniques and instruments, it integrates seamlessly into clinical workflows.
Approved Surgeries:
- Biopsies
- Ablations
- Spinal fusion
- Lymph vessel closure
INTRABEAM® 700 Platform – ZEISS
ZEISS’ INTRABEAM® 700 is a mobile radiotherapy system primarily used for intraoperative radiation therapy (IORT). It works alongside robotic-assisted procedures to deliver precise, low-energy X-ray radiation directly to the tumour bed during surgery. This targeted approach helps to destroy residual cancer cells whilst minimising exposure to surrounding healthy tissue.
Approved Surgeries:
- Neuro-oncology procedures
- Early-stage breast cancer
NAVIO™ Surgical System – Smith+Nephew
Smith + Nephew’s NAVIO™ is a handheld robotic-assisted system that uses real-time intraoperative navigation and image-free mapping to guide surgeons during knee replacement procedures. Instead of relying on preoperative CT scans, it builds a patient-specific model during surgery using anatomical landmarks. The system then provides visual and haptic feedback to help guide bone preparation and implant positioning.
Approved Surgeries:
- Unicompartmental knee arthroplasty
- Total knee arthroplasty
- Patellofemoral joint arthroplasty
CORI™ Surgical System – Smith+Nephew
Smith + Nephew’s CORI™ offers fast processing, a more compact form factor, and improved usability. It uses an image-free approach but delivers enhanced planning tools, real-time smart mapping, and robotic instrumentation for even greater precision and efficiency.
Approved Surgeries:
- Unicompartmental knee arthroplasty
- Total knee arthroplasty
- Revision knee arthroplasty
Mazor™ X Stealth Edition Robotic Guidance System – Medtronic
Medtronic’s Mazor™ X Stealth Edition is an advanced robotic guidance system designed for spinal surgery, integrating preoperative planning, real-time navigation, and robotic-assisted precision. The system also features cross-modality image registration, allowing it to match preoperative scans with intraoperative imaging for enhanced alignment.
Approved Surgeries:
- Spinal surgeries
ROSA® Knee Platform – Zimmer Biomet
Zimmer Biomet’s ROSA® Knee System is a robotic-assisted platform that uses real-time data and intraoperative imaging to guide surgeons in performing bone resections and positioning implants, ensuring optimal alignment and soft tissue balance. The system offers both image-based and imageless options, allowing flexibility in surgical planning.
Approved Surgeries:
- Total knee arthroplasty
ROSA® Hip Platform – Zimmer Biomet
Zimmer Biomet’s ROSA® Hip System is a robotic-assisted platform designed to enhance total hip replacement by improving acetabular component orientation and leg length accuracy. It uses fluoroscopy-based imaging to provide real-time intraoperative feedback, helping surgeons optimise implant positioning based on the patient’s unique anatomy.
Approved Surgeries:
- Total hip replacement
ROSA® Shoulder Platform – Zimmer Biomet
Zimmer Biomet’s ROSA® Shoulder System is a robotic-assisted platform that provides real-time intraoperative data, helping surgeons optimise glenoid and humeral component placement with enhanced precision. Using preoperative CT-based planning, the system enables personalised implant positioning, reducing complications linked to malalignment.
Approved Surgeries:
- Reverse total shoulder arthroplasty
- Anatomic total shoulder arthroplasty
ROSA® One Brain – Zimmer Biomet
Zimmer Biomet’s ROSA® Brain System is a robotic-assisted neurosurgical platform. The ROSA® Brain System features a robotic arm with six degrees of freedom, allowing precise instrument placement while avoiding critical structures. Surgeons use preoperative imaging and trajectory planning, which ROSA translates into real-time guidance, ensuring accuracy throughout the procedure.
Approved Surgeries:
- Stereoelectroencephalography (SEEG)
- Deep Brain Stimulation (DBS)
- Stereotactic biopsies
- Ventricular and trans nasal endoscopy
ExcelsiusGPS™ System – Globus Medical
Globus Medical’s ExcelsiusGPS™ System integrates real-time navigation and trajectory guidance, and features a rigid robotic arm that aligns with pre-planned trajectories. The ExcelsiusGPS™ system works with preoperative CT, intraoperative CT, and fluoroscopy, providing real-time visualisation of instruments and implants to enhance precision while reducing radiation exposure.
Approved Surgeries:
- Pedicle screw placement
- Minimally invasive and open spinal procedures.
- Cranial stereotactic procedures
HYDROS™ Robotic System – PROCEPT BioRobotics
PROCEPT BioRobotics’ HYDROS™ Robotic System is an AI-powered surgical robotics platform. It integrates advanced image guidance, AI-driven treatment planning, and robotic precision, allowing surgeons to perform heat-free, automated prostate tissue resection while preserving critical anatomy.
Approved Surgeries:
- Aquablation therapy
Dynamis Robotic Surgical System – LEM Surgical AG
LEM Surgical AG’s Dynamis Robotic Surgical System is a multi-arm robotic platform designed specifically for spine and other hard-tissue surgeries. Its three robotic arms, two for tools and one for navigation, allow dynamic tracking and stable control throughout the procedure.
Approved Surgeries:
- Placement of non‑cervical spinal pedicle screws
Monogram mBôs™ TKA System – Monogram Technologies
Monogram Technologies’ Monogram mBôs™ TKA System is a robotic-assisted platform. The Monogram mBôs™ TKA System integrates AI-driven automation, CT-based patient imaging, and next-generation navigation, enabling precise bone preparation and personalised implant fit.
Approved Surgeries:
- Total knee arthroplasty
Cirq® Arm System – Brain Lab
Brain Lab’s Cirq® Arm System is a modular robotic surgical platform, featuring a lightweight, flexible robotic arm with seven degrees of freedom. Cirq® allows precise instrument holding and trajectory alignment. Cirq ® integrates with Brainlab’s navigation systems, enabling real-time guidance for pedicle screw placement, stereotactic surgery, and SEEG electrode positioning.
Approved Surgeries:
- Spinal Surgery
- Cranial Surgery
TSolution One® System – THINK Surgical
THINK Surgical’s TSolution One® System is an active-autonomous robotic milling platform. TSolution One® System integrates CT-based preoperative planning, allowing surgeons to visualise and analyse the surgical outcome in 3D before the procedure. During surgery, the robot autonomously mills bone according to the planned implant placement, ensuring high accuracy and reproducibility.
Approved Surgeries:
- Total knee arthroplasty
Tmini® Miniature Robotic System – THINK Surgical
THINK Surgical’s TMINI® Miniature Robotic System is a handheld robotic platform, featuring a wireless robotic handpiece that assists surgeons in precise implant placement, automatically compensating for hand movement to ensure accuracy. The system integrates CT-based preoperative planning, allowing for real-time positional refinement and optimisation during surgery.
Approved Surgeries:
- Total knee arthroplasty
Genesis RMN System – Stereotaxis
Stereotaxis’ Genesis RMN System is a robotic magnetic navigation (RMN) platform designed for precise catheter control in endovascular interventions. It uses robotically controlled magnets to guide catheters with millimetre precision, enhancing procedural accuracy in electrophysiology and cardiac ablation.
Approved Surgeries:
- Electrophysiology procedures
- Cardiac ablation treatments
- Catheter-based interventions
Op.n GEN 1 Robotic Platform – eCential Robotics
eCential Robotics’ Op.n GEN 1 is a robotic-assisted surgical platform that integrates real-time navigation, intraoperative imaging, and robotic guidance to enhance precision in implant placement. Op.n GEN 1 features a robotic arm with seven degrees of freedom, allowing surgeons to align and position implants with submillimetre accuracy.
Approved Surgeries:
- Spinal fusion
- Screw placement
- Other spinal implant procedures
LIBERTY® System – Microbot Medical®
Microbot Medical®’s LIBERTY® is a single-use, remotely operated robotic system that enables interventional physicians to steer guidewires and catheters with precision, away from the radiation source, without requiring capital equipment or infrastructure upgrades.
Approved Surgeries:
- Peripheral endovascular procedures
