Arthrosurface nabs 510(k) clearance for patellofemoral WaveKahuna arthroplasty system

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.

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Arthrosurface acquires allograft tech from Wasas


ArthrosurfaceArthrosurface said today that it paid an unspecified amount to acquire an acellular dermal stabilization device technology from Wasas LLC.

Derived from human tissue, acellular dermis is made using a process that removes cells but retains portions of the extracellular matrix to create dermal allografts.

The deal includes the patent rights for the technology, which Franklin, Mass.-based Arthrosurface plans to develop and market “a platform of novel methods to be used to correct orthopedic challenges” for several indications. Wasas is based in Ft. Lauderdale.

“The availability of this allograft to Arthrosurface will allow us to execute on a pipeline of clinical applications that we have identified with our surgeon partners over the past several years,” CEO Steve Ek said in prepared remarks.

In March 2014 Arthrosurface won 510(k) clearance from the FDA for its ToeMotion Total Toe fixation system.