Globus Medical, Inc. (GMED) revealed on Wednesday that the FDA has granted 510(k) clearance for ExcelsiusFlex and Actify 3D Total Knee System.
ExcelsiusFlex will offer surgeons enhanced control, precise resections, and procedural adaptability in Total Knee Arthroplasty procedures for robotically guided resections.
The company said Actify 3D Total Knee System is designated for single use in skeletally mature individuals undergoing reconstruction of severely disabled and/or very painful joints and total knee replacement.
Globus Medical is ramping up production and preparing for commercial release soon.
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