Tyber Medical said today that its expanded line of anatomical plating systems has received FDA 510(k) approval.
After obtaining FDA approval, Tyber Medical, headquartered in Bethlehem, Pennsylvania, added mini fractures/small bones, long bone fractures, and ankle fractures/fusion plates to its products. The company designed the system to solve the problems of fractures, osteotomies, joint fusion, nonunion, and fusion of small bones and small bone fragments with the hand, wrist, foot, and ankle joints.
"Tyber Medical now provides a comprehensive electroplating solution that can connect different indications and proliferate throughout the body to address the trauma and deformity of long and short bones," Melissa Coale, director of research and development, in a press release Say.
Tyber Medical’s Long Bone Fracture Plate has a straight, low-contact locking plate and a 1/3 locking tubular plate. It combines mixed cortex/cancellous threat with variable angle locking and standard non-locking screws.
"Our second and largest FDA approval makes Tyber Medical a complete source of orthopedic plating for our partners and the surgeons they serve," said CEO Jeff Taber. “It’s been less than 12 months since we first received FDA approval. This highlights the speed at which we can use clinical research development, testing, and iteration to fill our partner’s portfolio with innovative solutions that benefit patient outcomes. Whitespace."
The company plans to launch a new fixed system in 2022 while seeking approval for the CE mark.
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