Globus Medical has won FDA clearance for its ExcelsiusFlex robotic ortho surgery navigations system in knee procedures — and an expanded indication for its ExcelsiusHub system.
Audubon, Pennsylvania-based Globus Medical received the 510(k) clearance on June 14 for the robotic positioning system, which was designed to help surgeons position implant components and prepare bony anatomy during orthopedic procedures.
“We are ramping up production and targeting commercial release in the fourth quarter,” a Globus spokesperson told MassDevice today.
“We are excited to have received 510(k) clearance by the FDA for ExcelsiusFlex with Total Knee Arthroplasty (TKA) application,” the spokesperson said in a email. “This new robotic navigation platform joins the already best-in-class Excelsius Ecosystem, designed to offer surgeons enhanced control, resection accuracy, and procedural flexibility to Total Knee Arthroplasty.”
“ExcelsiusFlex is indicated to assist the surgeon in primary total knee arthroplasty procedures for guided resections based on implant placement planning,” she continued. “Multiple workflows and unrestricted jig-less resections restores control of the saw and the procedure to the surgeon. Streamlined user software enable efficient procedures.”
In 2017, Globus Medical won FDA clearance for its Excelsius GPS robot-assisted surgery platform for spine. The company launched its Excelsius3D intraoperative, image-guided robotic navigation in 2022 for use with Excelsius GPS. Excelsius3D was designed for more accurate implant placement, less radiation exposure and shorter operative times.
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Globus Medical’s ExcelsiusFlex 510(k) summary
Globus Medical used Excelsius GPS as the primary 510(k) predicate for ExcelsiusFlex, listing four other predicates: Globus Medical’s ExcelsiusHub and AQrate Robotic Assistance System, Stryker’s Mako Total Knee Application, and the Johnson & Johnson Medtech DePuy Synthes Velys Robotic-Assisted Solution.
Globus Medical’s 510(k) summary describes ExcelsiusFlex as “a robotic positioning system with a computer controlled robotic arm, hardware and software that works in conjunction with ExcelsiusHub to enable real time surgical navigation and robotic guidance using patient tracking arrays and a positioning camera.”
“The system assists the surgeon in implant placement planning and intraoperative tracking of patient anatomy by locating anatomical structures and stereotaxic positioning of surgical instruments relative to patient CT images or directly acquired anatomical structures,” the company continued in its filing. “The navigation and guidance system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient’s anatomy) or directly acquired anatomical structures. Once this registration is created, the software positions the robotic arm on a planned resection plane.”
The ExcelsiusFlex system includes end effectors and instruments for patient tracking, patient attachment and navigation.
The 510(k) clearance also expanded the previous indication for ExcelsiusHub to include orthopedic device planning and identification through directly acquired anatomical structures.
Globus Medical makes knee reconstruction implants under the similar Gen-Flex/GenFlex2 names. Globus Medical’s 510(k) summary materials say ExcelsiusFlex is compatible with the GENflex2 and the Actify total knee system.
The Actify system is not yet listed on Globus Medical’s website, but the FDA gave it 510(k) clearance on June 20, classifying it as a cemented, semi-constrained, polymer/metal/polymer patellofemorotibial knee prosthesis.
Globus robotic procedure growth accelerates
Globus has said in recent months that the robot was on the way. In November, Globus President and CEO Dan Scavilla said the company planned to launch a knee robot in the first half of 2024.
“With that comes, obviously, the cementless knee, which I think will be the major player there and that is well progressing on a good pace,” Scavilla said, according to a Seeking Alpha transcript of the Q3 2023 earnings call. “I think 2024, we’ll start talking obviously more about the joints in total.”
Last month, Scavilla said the company had filed for regulatory review of the robot.
“We’re building inventory, getting ready to roll it out,” he said on the Q1 2024 earnings call, later describing the robot as “one of the most exciting things I think we’ll get out the door this year.”
“The ortho robot coming out … will allow us to have more volume ramp-up of our implants of knees and hips,” Scavilla later continued.
Procedures using Globus robots in Q1 grew 15% over the same quarter the year before, he said, pushing total robotic procedures past 71,000 since launch.
Globus also expects an augmented reality headset to win FDA approval in the latter half of this year.
“That’s one where we need to get that filed and approved through,” Scavilla said in May. “We feel good about it. We’re ready to do it, but it’s in queue right now just to get through our processes.”
Globus is still working through its merger with NuVasive, laying off employees at the former NuVasive headquarters in San Diego earlier this year.
This post was originally published on June 21, 2024, and updated on June 25 with the FDA clearance of Globus Medical’s Actify knee system.
