Fuse Medical announced today that it received FDA 510(k) clearance for its tibial revision knee system and stabilized tibial insert.
Richardson, Texas-based Fuse Medical’s tibial revision knee system and the PS Plus posterior stabilized tibial insert represent the latest additions to the company’s Sterizo total knee system.
According to a news release, the Sterizo tibial revision knee system offers surgeons a stemmed option in a primary total knee arthroplasty for patients with higher body mass index (BMI) or requiring additional stability, along with tibial augments to address anatomical defects.
The platform constitutes the basis of the Sterizo total revision knee system, which Fuse currently has under development with an eye on an initial launch in late 2022.
Fuse’s Sterizo PS Plus posterior stabilized tibial insert provides increase varus/valgus constraint and limits internal/external rotation when compared to the standard Sterizo posterior stabilized tibial insert in an effort to accommodate patients requiring more constraint.
The company said the product line extension will complement the offerings currently available with the Sterizo primary total knee system, which include cruciate retained, ultra congruent/anterior stabilized and posterior stabilized options.
“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,” Fuse CEO Christopher C. Reeg said in the release. “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.
“Adding these new options to the already robust Sterizo platform allows us to better target new distribution and sales channels. These new products, along with our future product development pipeline, will also assist in attracting experienced sales professionals in our industry. Our priority at Fuse remains to provide innovative solutions for today’s clinical challenges and assist with improving surgical outcomes.”