Tyber Medical Announces FDA 510(k) approval for anatomical plating systems
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Tyber Medical LLC announced it has received FDA 510(k) clearance for its expanded line of anatomical plating systems, according to a company press release.
The line includes more than 73 different indication‐specific anatomical plating families.
“Our second and largest FDA clearance makes Tyber Medical a complete source for orthopedic plating for our partners and the surgeons they serve,” Jeff Tyber, the CEO of the company, said in the release. “It's been less than 12 months from our first FDA clearance, underscoring the speed at which we can utilize our clinical research to develop, test, and iterate to fill the gaps in our partners’ product portfolios with innovative solutions that benefit patient outcomes.”
Mini‐fragment/small bone, long bone fracture and ankle fracture/fusion plates are some of the indication categories included in the clearance, with variable locking compression plates and screws of varying lengths and compressions to aid in reconstruction and revision surgeries, according to the release.
“Tyber Medical now offers a comprehensive plating solution that bridges different indications and proliferates throughout the entire body to address trauma and deformity to the long and short bones,” Melissa Coale, director of research and development at the company, said in the release.
The systems include “hybrid cortical/cancellous thread featuring both variable angle locking and standard non‐locking screws” for stabilization of fractures, osteotomies and fusions of small bones and small bone fragments of the hand, wrist, foot and ankle. Tyber Medical is pursuing a CE mark and plans to launch the new fixation systems in 2022.
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