05.06.14
JustRight Surgical LLC, a micro-laparoscopic medical device company focused on 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, is designed to be used by surgeons in pediatric and general surgery where access is limited and visibility is reduced. The stapler is the third product from the company to win FDA clearance since its 2010 founding. JustRight Surgical is privately held by local investors who have supported the company with $15 million in capital contributions.
The stapler, the smallest classic stapler on the market, is designed to be used by surgeons in pediatric and general surgery where access is limited and visibility is reduced. The stapler is the third product from the company to win FDA clearance since its 2010 founding. JustRight Surgical is privately held by local investors who have supported the company with $15 million in capital contributions.
The company calls its 5mm stapler a "major step forward" for pediatric device development.
“The needs of our smallest patients are unique, yet the surgical tools available to surgeons for these cases are virtually non-
existent,” said Steve Rothenberg, M.D., 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.”
Features of the JustRight 5mm Stapler include: a size that is nine times smaller than existing stapling instruments; security of the gold standard "B" staple formation; flexibility in stapler placement with a 5 mm shaft diameter; smooth and efficient stapling and cutting in one motion; optimal jaw length for maneuverability into small spaces; and easy repositioning with 360-degree jaw rotation.
“The absence of innovation in this market is primarily due to minimal financial incentives for large companies to develop these micro instruments,” said Russ Lindemann, president and CEO of JustRight Surgical. “As a result, pediatric surgeons are forced to use
devices originally designed for adults. These instruments can be oversized, overpowered and difficult to maneuver in small patients and tight spaces. We felt it was critical to answer the call for smaller devices and expand the options available.”
Founded in 2010, JustRight Surgical develops precisely-designed surgical instruments that allow access to confined and often delicate structures.The company is based in Boulder, Colo.