Tyber Medical receives FDA 510(k) clearance for distal radius plating system
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Key takeaways:
- Tyber Medical received FDA 510(k) clearance of its novel distal radius plating system.
- The system is designed for patients with fractures, fusions, nonunions and malunions.
Tyber Medical LLC has announced FDA 510(k) clearance of its novel distal radius plating system, according to a press release.
The system is designed for patients who require plate fixation for fractures, fusions, nonunions, malunions or osteotomies of the radius, ulna or hand, according to the release.
“The Tyber Medical Distal Radius System provides an innovative approach to address one of the most common fractures,” Jeff Tyber, president of CEO of Tyber Medical, said in the release. “Additionally, the enhanced ergonomic design delivers a solution to reduce flexor tendon irritation, a common postoperative concern,” Tyber said.
“Our engineering team did a great job keeping the design under the watershed line while maintaining low prominence and the ability to reach the radial styloid,” David Hannah, chief technology officer of Tyber Medical, said in the release. “They recognized the need for an additional locking head size to accomplish this in the flexor tendon and narrow volar plates, and now we get to add that locking mechanism to our portfolio,” Hannah added.