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Globus Medical received FDA 510(k) marketing clearance for ExcelsiusFlex with Total Knee Arthroplasty (TKA) application. This new robotic navigation platform joins GMED’s Excelsius ecosystem, designed to offer surgeons control, resection accuracy and procedural flexibility in total knee arthroplasty. Additionally, the company received 510(k) clearance for the ACTIFY 3D Total Knee System that will pair with ExcelsiusFlex.
The company is ramping production and preparing for commercial release in the near future.
ExcelsiusFlex is engineered to assist the surgeon in primary total knee replacement procedures for robotically guided resections based on their implant placement planning. Multiple workflows and unrestricted jig-less resections are offered to restore control of the saw and the procedure to the surgeon. Streamlined user software is designed to enable efficient procedures.
The ACTIFY 3D Total Knee is designed to pair cementless reconstruction with operative efficiency and anatomic fit. Whether through manual or robotic-assisted workflows, ACTIFY 3D is additively engineered to combine strength and a porous lattice interface conducive to cementless fixation. The system provides a suite of implants and instruments to address surgeon preferences and varying anatomy in a diverse patient population.
ExcelsiusFlex when used in conjunction with ExcelsiusHub is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons for navigating and/or guiding compatible surgical instruments provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or directly acquired anatomical structures. The system is indicated to assist the surgeon in planning the position of the implant components and preparing the bony anatomy during orthopedic procedures.
The TKA implant systems compatible with ExcelsiusFlex are GENflex2 and ACTIFY Total Knee.
The ExcelsiusHub is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans, fluoroscopy or directly acquired anatomical structures. The system is indicated for the planning of orthopedic devices and placement of spinal and orthopedic bone screws and interbody fusion devices.
ACTIFY Total Knee and ACTIFY 3D Total Knee are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. ACTIFY Total Knee is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use. ACTIFY 3D Total Knee is indicated for cemented and uncemented use.
“With the addition of ExcelsiusFlex and ACTIFY 3D, we look forward to introducing next generation robotic technology along with the next generation of implant technology to the orthopedic market,” commented Dan Scavilla, president and CEO of Globus Medical. “The precision, efficiency and flexibility these systems offer will help to provide surgeons a best-in-class solution for treating patients.”
Source: Globus Medical, Inc.
Globus Medical received FDA 510(k) marketing clearance for ExcelsiusFlex with Total Knee Arthroplasty (TKA) application. This new robotic navigation platform joins GMED's Excelsius ecosystem, designed to offer surgeons control, resection accuracy and procedural flexibility in total knee arthroplasty. Additionally, the company received 510(k)...
Globus Medical received FDA 510(k) marketing clearance for ExcelsiusFlex with Total Knee Arthroplasty (TKA) application. This new robotic navigation platform joins GMED’s Excelsius ecosystem, designed to offer surgeons control, resection accuracy and procedural flexibility in total knee arthroplasty. Additionally, the company received 510(k) clearance for the ACTIFY 3D Total Knee System that will pair with ExcelsiusFlex.
The company is ramping production and preparing for commercial release in the near future.
ExcelsiusFlex is engineered to assist the surgeon in primary total knee replacement procedures for robotically guided resections based on their implant placement planning. Multiple workflows and unrestricted jig-less resections are offered to restore control of the saw and the procedure to the surgeon. Streamlined user software is designed to enable efficient procedures.
The ACTIFY 3D Total Knee is designed to pair cementless reconstruction with operative efficiency and anatomic fit. Whether through manual or robotic-assisted workflows, ACTIFY 3D is additively engineered to combine strength and a porous lattice interface conducive to cementless fixation. The system provides a suite of implants and instruments to address surgeon preferences and varying anatomy in a diverse patient population.
ExcelsiusFlex when used in conjunction with ExcelsiusHub is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons for navigating and/or guiding compatible surgical instruments provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or directly acquired anatomical structures. The system is indicated to assist the surgeon in planning the position of the implant components and preparing the bony anatomy during orthopedic procedures.
The TKA implant systems compatible with ExcelsiusFlex are GENflex2 and ACTIFY Total Knee.
The ExcelsiusHub is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans, fluoroscopy or directly acquired anatomical structures. The system is indicated for the planning of orthopedic devices and placement of spinal and orthopedic bone screws and interbody fusion devices.
ACTIFY Total Knee and ACTIFY 3D Total Knee are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. ACTIFY Total Knee is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use. ACTIFY 3D Total Knee is indicated for cemented and uncemented use.
“With the addition of ExcelsiusFlex and ACTIFY 3D, we look forward to introducing next generation robotic technology along with the next generation of implant technology to the orthopedic market,” commented Dan Scavilla, president and CEO of Globus Medical. “The precision, efficiency and flexibility these systems offer will help to provide surgeons a best-in-class solution for treating patients.”
Source: Globus Medical, Inc.
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
