The Mazor SpineAssist was the first robot approved by the FDA to guide the placement of pedicle screws in 2004.
Since then, the market has developed rapidly, with several medical device companies launching their own versions of spine robots, with many more yet to come.
Robots have been lauded by many surgeons for limiting radiation exposure and their improved precision, which translates to better outcomes and quicker recoveries for patients. However, disadvantages of the technology include high costs, steep learning curves and inherent technological glitches.
Here is a breakdown of spine robots at seven device companies:
1. Mazor X (Medtronic)
Medtronic acquired Mazor Robotics for $1.7 billion in 2018, as part of its plan to integrate its spinal implants, navigation and 3D imaging technology with the Mazor X robotic guidance system.
In 2019, Medtronic launched the Mazor X Stealth Edition for spine surgery, which allows surgeons to create personalized 3D surgical plans before surgery and holds surgical instrumentation in place with a robotic arm during spine procedures.
The Mazor X costs about $850,000 with each surgery resulting in about $1,500 in disposables sales.
2. ExcelsiusGPS (Globus Medical)
Globus Medical acquired Excelsius in 2014 for an estimated $40 million and earned CE Mark approval for ExcelsiusGPS in the European Union in January 2017. The FDA provided 510(k) clearance for the system in August 2017.
The device combines a robotic arm with navigation to improve accuracy in the placement of screws during spine surgery and reduce radiation exposure for the surgical team.
The platform costs more than $1 million per unit and supports screw placement in several approaches including posterior cervical, posterior thoracic sacroiliac and posterior lumbar.
3. Rosa Spine (Zimmer Biomet)
Zimmer Biomet acquired Medtech SA for at least $132 million in 2016. Medtech developed the Rosa Brain and Rosa Spine robotic-assisted surgery systems, which cost about $700,000 each.
Rosa Spine was cleared by the FDA in 2016 and the company's new technology — the Rosa One Spine System — received FDA approval in March 2019.
Rosa One Spine also combines robotics and navigation with real-time patient tracking capability, assisting surgeons in minimally invasive and complex thoracolumbar spine procedures.
4. NuVasive (Pulse)
NuVasive submitted its Pulse system and associated robotics application for approval in February, and hopes to launch the system this summer.
Pulse is an open-imaging platform integrated with Siemens' 3D mobile C-arm, Cios Spine. The robot is expected to have applications for all spinal surgeries, not just complex or low-acuity cases.
Pulse features neuromonitoring, surgical planning, radiation reduction and rod-bending technologies, as well as imaging and navigation functions.
5. Brainlab (Cirq)
In February, Brainlab received FDA approval for two surgical robots: the Cirq spine system and the Loop X Mobile Imaging Robot.
The Cirq robotic alignment module assists surgeons during spine procedures and the Loop-X is the first fully robotic intraoperative imaging device on the market, according to Brainlab.
Both devices received a CE mark in mid-2020.
6. Curexo (Cuvis-spine)
South Korean devicemaker Curexo received FDA licensing for its spine robot in May. The robot is also designed for the placement of pedicle screws and to reduce radiation exposure for staff and patients.
The FDA license is the third that the robot has achieved, and it can now be supplied to all countries. Curexo plans to expand their market to Europe and the U.S. soon.
7. Fusion Robotics (Fusion Robotics System)
Fusion Robotics received FDA clearance for its spine robot in February.
The Fusion Robotics System, a 3D imaging navigation and robotic targeting system for spine surgery, is designed to improve spine procedural efficiency "with significantly less expense," compared to currently available robotic systems, according to the company.
The robot is being commercialized in the U.S. throughout 2021.