CoNextions receives FDA 510(k) clearance for tendon repair system
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CoNextions Inc. has announced FDA 510(k) clearance of the CoNextions TR tendon repair system for traumatic tendon lacerations in the hand, wrist and forearm, according to a press release.
The CoNextions TR tendon repair system allows for a stronger and more efficient repair of tendon lacerations with a lower failure and rupture rate compared with conventional suture, according to the release.
“We are pleased with the outcome of the FDA’s review of our 510(k) submission supported by a 90-patient clinical trial and are excited about the upcoming introduction and commercial launch of the product,” Jeffrey Barnes, president and CEO of CoNextions, said in the release.
“Our network of independent sales distributors is well positioned to offer the CoNextions TR device to orthopedic surgeons both in the U.S. and abroad as a better alternative to the current standard of care,” Dan Gruppo, executive vice president of sales and marketing at CoNextions, added.
According to the release, CoNextions is expected to launch the system in May of 2022.
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