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Of the four enabling technology clearances highlighted this month, perhaps the one most highly anticipated is Globus Medical’s entry into the robotic-assisted knee replacement market.
We also present the latest clearance for DePuy Synthes’ VELYS and spine-adjacent systems from Providence Medical and VUZE.
Globus Medical | ExcelsiusFlex, K240721
Submitted March 2024, granted June 2024
Primary predicate: Globus Medical ExcelsiusGPS, K171651
FYI: ExcelsiusFlex is 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 submission sought clearance for ExcelsiusFlex and navigated instruments for bone preparation for primary total knee arthroplasty and expanded indications for use with ExcelsiusHub.
Additionally, the company received 510(k) clearance for the ACTIFY Total Knee and 3D Total Knee that will pair with ExcelsiusFlex. The total knee implant systems compatible with ExcelsiusFlex are GENflex2 and ACTIFY 3D Total Knee.
DePuy Synthes | VELYS Robotic-Assisted Solution, K240211
Submitted January 2024, granted June 2024
Primary predicate: Stryker Mako Partial Knee Application, K172301
FYI: Subject clearance addresses use of VELYS in unicompartmental knee arthroplasty (UKA) in medial and lateral procedures. VELYS for UKA is compatible with the SIGMA HP Unicondylar Knee and reusable INTUITION INSTRUMENTS.
The platform’s features include the PROADJUST PLANNING SCREEN to help ensure precise implant placement, alignment and balance relative to soft tissue and an ACCUBALANCE GRAPH for personalized joint balancing throughout the full range of motion.
Providence Medical Technology | CORUS Navigation Access, K240625
Submitted March 2024, granted May 2024
Primary predicate: Medtronic Sofamor Danek USA Navigated Anterolateral Disc Prep Instruments, K211441
FYI: The CORUS Navigation Access System is cleared for use with the CORUS Spinal System. CORUS Navigation is specifically designed for use with Medtronic’s StealthStation for posterior spinal fusion and assists surgeons in locating, accessing and preparing facet joints for posterior fusion. It enables surgeons to utilize surgical navigation to perform procedures with the CORUS Spinal System.
VUZE Medical | Spine Surgery Guidance System, K232976
Submitted September 2023, granted May 2024
Primary predicate: VUZE Medical Imaging System for Spinal Interventions, K210830
FYI: The focus of this second-generation VUZE System is minimally invasive thoracolumbar stabilization. However, the underlying VUZE technology is not specific to any particular anatomy and the company intends to seek regulatory clearances for further spinal and skeletal interventions.
VUZE enables users to load 3D images and planning data into the system, and then register and overlay this data in real time with intraoperative 2D radiographic images of the same anatomy.
The system supports device guidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation, fixation coupled with fusion, vertebroplasty or kyphoplasty.
