FDA clears wave of Globus Medical devices

Orthopedic

Globus Medical continues to grow and expand its orthopedic trauma product portfolio with a new wave of FDA clearances. 

The company has introduced several new system extensions so far in 2024 and received 510(k) clearance from the FDA for its first suture-based product, the Tensor suture button system, according to an Oct. 2 press release. 

Newly launched, next-generation systems include Anthem II distal radius volar plates, Autobahn trochanteric nail PRO instruments and Captivate Sola headless screws.

Asif Ilyas, MD, a physician at Thomas Jefferson University Hospital in Philadelphia, was one of the first users of the new Anthem II volar plates, which are designed to treat a wide variety of wrist fractures with anatomically contoured plates for intraoperative versatility. "The contour of the Anthem II volar plates and comprehensive fixation options allow me to further customize my surgical plans and achieve an anatomic fit," said Dr. Ilyas.

The Tensor system features a self-locking suture and an inserter with integrated tensioning handles to streamline  tensioning through a single incision.

The Autobahn is designed to treat a variety of pertrochanteric femur fractures, while the Captivate headless screws address fracture repair, bone reconstruction, osteotomy and arthrodesis procedures through ample implant options and shared instruments for paired screw sizes.

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