OrthoDynamix LLC Receives FDA 510(k) Clearance for ArthroSteer(R) 3.5mm Ablator
JACKSONVILLE, Fla., March 2 /PRNewswire/ -- OrthoDynamix announced today that it has received FDA clearance for its new device, ArthroSteer 3.5mm 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 primarily the hip.
Approximately 40 million Americans are affected by joint pain due to multifactorial causes. There are over 1 million annual surgical interventions of the knee with over 300,000 shoulder and hip procedures.
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 3.5mm and/or its 5mm 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.
"ArthroSteer's 3.5mm Ablator FDA clearance is an important step for increased sales opportunity in the US," said Bill Dennis, CEO of OrthoDynamix. "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."
Advanced and differentiated products for sports medicine, the ArthroSteer's 3.5mm Ablator is designed to withstand the rigors of arthroscopy. It is also designed for cost savings since it interfaces with many of the hospital's current mono polar electrosurgical generators, thus additional capital equipment is not required.
About OrthoDynamix LLC
Based in Jacksonville, Florida, OrthoDynamix is a privately held medical device company dedicated to the development and commercialization of the next generation of steerable sports medicine devices. The minimally invasive product line is designed to address pain issues from pre-arthritis and sport injuries.
CONTACT: Bill Dennis at OrthoDynamix, 904-641-2599
SOURCE OrthoDynamix LLC