OrthoDynamix Receives FDA 510(k) Clearance for ArthroSteer 3.5-mm Ablator

Jacksonville, Fla.-based OrthoDynamix has received FDA clearance for its new device, the ArthroSteer 3.5-mm Ablator, a mono polar electrosurgical device for general surgical use, including the orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulating soft tissue in, but not limited to the knee, shoulder and hip, according to a OrthoDynamix news release.

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ArthroSteer’s patent-pending technology improves triangulation and or orientation of its instruments in tight joint capsules enabling the surgeon greater access to damaged tissue.  The 3.5-mm and/or its 5-mm high dexterity instruments have surgeon controlled 180-degree bend of the distal shaft while the tip can rotate 360 degrees on its axis, independent of the shaft, according to the release.

“ArthroSteer’s 3.5-mm Ablator FDA clearance is an important step for increased sales opportunity in the U.S.,” Bill Dennis, CEO of OrthoDynamix, said in the release. “This product complements our unique sports medicine portfolio of steerable ArthroSteer Punch, Grasper and Biter that are currently marketed in the US. This product portfolio is also being readied for the global market upon receipt of their CE mark.”

Read the OrthoDynamix release on the ArthroSteer 3.5-mm Ablator.

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