Arthrosurface Gains FDA Clearance of Patellofemoral WaveKahuna System

By Julie A. Vetalice

Arthrosurface gained FDA 510(k) clearance to market the Patellofemoral (PF) WaveKahuna Arthroplasty System, an extension of its HemiCAP® Patellofemoral & PF Wave lines offering larger implant sizes.

PF WaveKahuna is designed to spare native anatomy while treating tracking and stability conditions of the Patella and Femoral Trochlea, and combines clinical benefits of both the anatomic and dome patella implants from the PF Wave system, which is indicated for patients who have more diffuse or extensive damage to the PF joint.

The femoral component of WaveKahuna is designed to mate with the Arthrosurface PF Wave Fixation Component, and the existing surgical technique is unchanged though adds a superior ream step.

Sources: Arthrosurface, Inc.; ORTHOWORLD Inc.

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory