Arthrosurface said last month that it won 510(k) clearance from the FDA for its patellofemoral WaveKahuna arthroplasty system.
The Franklin, Mass.-based company’s PF WaveKahuna device is designed to restore the articular surface geometry of the patella and femoral trochlea. The system tackles the challenging PF tracking and stability conditions and gives increased coverage of the trochlear groove, according to Arthrosurface.
The company also noted that the device’s design combines the clinical benefits of the anatomic and dome patella implants from the PF Wave system. The PF WaveKahuna femoral component can match up with the company’s PF Wave Fixation component, Arthrosurface added.
“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,” Shane Shankle, VP of U.S. sales, said in prepared remarks.
“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,” Dawn Wilson, VP of quality & regulatory, added.
In April, Arthrosurface won FDA 510(k) clearance for its OVOMotion shoulder arthroplasty system.
The company explained that its newly-cleared stemless total shoulder system is designed to minimize bone removal specifically for patients with painful or severely disabled shoulder joints from arthritis, traumatic events or avascular necrosis.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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