Royal Biologics Gains FDA 510(k) for Maxx Concentration System

By Julie A. Vetalice

Royal Biologics Gains FDA 510(k) for Maxx Concentration System

Royal Biologics announced FDA 510(k) clearance of their Maxx™-PRP concentration system. Maxx-PRP is a patented next-generation concentration device that can be used to concentrate autologous whole blood for the safe and rapid preparation of platelet-rich plasma to use point of care for mixing with autograft and/or allograft to improve handling characteristics. Royal's Maxx-PRP system offers "customizable formulations" of platelet-rich plasma, allowing clinicians to treat a variety of conditions in orthopedics, sports medicine, plastic surgery and regenerative medicine.

Maxx-PRP's patented lead screw technology allows users to customize various platelet-rich plasma formulations within seconds at their fingertips. Multiple formulation options such as Leukocyte Rich (LR-PRP), Leukocyte Poor (LP-PRP) and Platelet Pure Plasma (P-PRP) are easily achieved within minutes. Maxx-PRP also allows users to perform two concentration cycles in one device, in under 10 minutes. This novel technology sets a new bar in the orthopedic and regenerative medicine industry for concentration times, customizable formulations and efficiency.

Maxx-PRP is the latest product launch in Royal Biologics continuous expansion of their Autologous and Live Cellular (ALC) Technology portfolio. Royal Biologics has now launched three novel systems in their ALC portfolio that provide an efficacious and cost-benefit advantage to clinicians and hospital systems.

Source: Royal Biologics

Product Labels: PRP/Cell-Based/Osteoinductive Materials

Tags: 510(k) Clearance, Regulatory