FDA clears orthopedics robot for TKA from Globus Medical

2024-06-21

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Globus Medical has won FDA clearance for its new ExcelsiusFlex orthopedics robot. Audubon, Pennsylvania-based Globus Medical received the 510(k) clearance on June 14 for the robotic positioning system. “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. Related: 10 surgical robotics companies you need to know 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 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 does not yet appear to have been approved by FDA or listed on Globus Medical’s website, but the company last year applied to trademark Actify for “orthopedic joint implants and surgical instruments used to implant orthopedic joint implants.” 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.

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