Fuse Medical Gets FDA 510(k) Clearance for Leg and Knee Inserts

Fuse Medical has received the FDA’s 510(k) clearance for its Sterizo tibial revision knee system and its Sterizo PS Plus posterior stabilized tibial insert, both part of the company’s Sterizo total knee arthroplasty system.

The tibial revision knee system, which includes a range of femoral and tibial stems, offsets, and augments, offers options for patients with a higher body mass index or who require additional stability, as well as tibial augments to address anatomical defects.

The PS Plus posterior stabilized tibial insert is designed to limit internal and external rotation for patients who require more constraint, the company said.