Fuse Medical received FDA clearance for its tibial revision knee system and PS Plus posterior stabilized tibial insert, according to an Aug. 26 news release.
Both products are part of the company's Sterizo total knee system. The revision system provides a stemmed option for total knee replacement patients with higher BMIs or who need extra stability. The PS Plus insert is designed to accommodate patients who need more constraint.
"With our Sterizo Tibial Revision Knee System cleared for use in primary applications, we can now offer the additional options surgeons may need to meet specific patient anatomy requirements," CEO Christopher Reeg said. "The expansion of offerings for our Sterizo Total Knee System demonstrates our continued commitment to develop and expand our portfolio of Fuse manufactured medical device products."