JustRight Surgical, a micro-laparoscopic medical device company devoted to miniaturizing surgical instrumentation, has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for its JustRight™ 5mm Stapler. The stapler, the smallest classic stapler on the market, will be used by surgeons in pediatric and general surgery where access is limited and visibility is reduced. This is the third product from the company to win FDA clearance since its founding in 2010. JustRight Surgical, LLC is privately held by local investors who have supported the company mission over the last 2 years with $15 million in capital contributions.
For the pediatric surgical community in particular this device represents a major step forward. Medical device options configured specifically for pediatric surgery have been limited. Since 1972, when pediatric surgery became a recognized subspecialty, surgeons have been asking companies to miniaturize instrumentation to better serve infants and children requiring surgery.
"The needs of our smallest patients are unique, yet the surgical tools available to surgeons for these cases are virtually non-existent," said Dr. Steve Rothenberg, medical advisor and co-founder of JustRight Surgical. "In the electronics industry, miniaturization happens almost faster than we can absorb the changes. Meanwhile, the downsizing of surgical instrumentation has remained stagnant and we have made it our mission to change that."
