Regulatory

Arthrosurface receives FDA Clearance of Patellofemoral WaveKahuna Arthroplasty System

FRANKLIN, Mass.June 29, 2018 /PRNewswire/ — Today, Arthrosurface, Inc., a leading provider of minimally invasive, motion preserving joint restoration systems, announces their recent FDA 510(k) Clearance to market the Patellofemoral (PF) WaveKahuna Arthroplasty System. The PF WaveKahuna Arthroplasty System is a line extension to The Company’s previously cleared and commercially marketed family of HemiCAP® Patellofemoral & PF Wave Systems.

Shane Shankle, VP of US Sales expressed, “As a market leader in Patellofemoral Arthroplasty, we are very excited to round out our line with the PF WaveKahuna System. The larger implants will allow a surgeon to choose from a wide range of size offerings to better serve the patient’s needs and allow them to maintain their quality of life.”

The PF WaveKahuna restores the unique articular surface geometry of the Patella and Femoral Trochlea while maintaining the patient’s native anatomy. It’s innovative, extended lateral aspect and trochlear geometry is designed to address challenging Patellofemoral tracking and stability conditions as well as providing increased coverage of the trochlear groove. Furthermore, the novel patella design combines the clinical benefits of both the anatomic and dome patella implants from the PF Wave System. Additionally, the PF WaveKahuna femoral component is designed to mate with the currently marketed Arthrosurface PF Wave Fixation Component. The existing surgical technique is unchanged, with the addition of a superior ream step.

“The FDA clearance comes shortly after data recently presented at ESSKA confirmed significantly improved postoperative outcomes with high patient satisfaction and no progression of knee arthritis at 5 years follow-up. The timing could not be better,” said Dawn Wilson, VP of Quality & Regulatory.

About Arthrosurface: Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. Arthrosurface is the inventor and market leader in joint preservation with inlay arthroplasty. Our product offerings include joint preservation implants, instruments and orthobiologics. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 14 years. For more information, please visit our website at www.arthrosurface.com

 

SOURCE Arthrosurface, Inc.

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Drue De Angelis

Drue is Managing Partner for The De Angelis Group, Executive Search firm exclusively for the Ortho & Spine industry.

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