STERIBITE, LLC, a medical device company focused on developing unique, disposable surgical instruments, today announced it has received 510(k) clearance from the FDA to market its first product, the patented STERIBITE DISPOSABLE KERRISON RONGEUR.
Kerrison rongeurs are instruments used to remove bone on all spine procedures and are critical in one of the stages of the operation; however reusable Kerrison rongeurs are difficult to clean, raising the risk of possible infection to the patients. They are also expensive and difficult to maintain and keep sharp, which is frustrating for spine surgeons and increases the risk for patients.
STERIBITE, LLC Chief Executive Officer John A. Redmond offers: "We are extremely pleased with the FDA clearance and know the STERIBITE disposable kerrison will provide a simple, safe and cost effective solution to the problems associated with reusable kerrison rongeurs. We set out to create a better designed rongeur that eliminates all the problems associated with reusable ones, with the added safety of being totally disposable, and I am confident we have succeeded. We look forward to introducing this exciting product in the U.S. early in the first quarter of 2019."
STERIBITE, LLC is a privately held medical device company and was developed by RJR Surgical, Inc., a Cleveland, Ohiobased company.