DePuy Synthes receives FDA 510(k) clearance of spine system, navigation instruments
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Key takeaways:
- DePuy Synthes received FDA 510(k) clearance of the TriALTIS spine system and navigation-enabled instruments.
- The TriALTIS system is projected to be available in the U.S. in 2024.
Johnson & Johnson MedTech has announced DePuy Synthes received FDA 510(k) clearance of the TriALTIS spine system and navigation-enabled instruments, according to a press release.
The TriALTIS spine system is a posterior thoracolumbar pedicle screw system for patients with degenerative, tumor, trauma and deformity pathologies. The TriALTIS navigation-enabled instruments include drills, taps and screwdrivers that can be used with or without navigation, according to the release.
“The TriALTIS spine system will be our premier pedicle screw platform designed to work seamlessly across our entire DePuy Synthes portfolio of enabling technology solutions,” Russell Powers, worldwide president of spine at DePuy Synthes, said in the release. “Johnson & Johnson MedTech is proud to deliver this exciting innovation that can help facilitate the surgical treatment of spinal degeneration and deformity with the goal to improve fixation, drive better patient outcomes and potentially reduce the clinical and economic burden associated with the current standard of care. DePuy Synthes has been a leader in the complex spine space for over 35 years, and the launch of the TriALTIS spine system will mark a critical milestone toward our vision to continue this legacy long into the future,” Powers said.
According to the release, the TriALTIS spine system is projected to be available in the U.S. in 2024.
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