FDA Clears Fuse Medical’s Sterizo Revision Knee, PS Tibial Insert

Fuse Medical Inc., an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace, received its latest U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s Tibial Revision Knee System, and the PS Plus Posterior Stabilized Tibial Insert, the latest additions to the Sterizo Total Knee System.
 
The Sterizo Tibial Revision Knee System provides the surgeon a stemmed option in a primary total knee arthroplasty for patients with higher Body Mass Index (BMI) or requiring additional stability, as well as tibial augments to address anatomical defects. The Tibial Revision Knee System is the basis for the Sterizo Total Revision Knee System, which is currently under development and slated for initial launch in late 2022. The Sterizo Total Revision Knee System will be fully compatible with the Sterizo Primary Total Knee System and offer a full range of femoral and tibial stems, offsets, and augments.
 
The Sterizo PS Plus Posterior Stabilized Tibial Insert provides increased varus/valgus constraint and limits internal/external rotation as compared to the standard Sterizio Posterior Stabilized Tibial Insert, accomodating patients that require more constraint. This product line extension will complement the offerings currently available with the High Flexion engineered Sterizo Primary Total Knee System, which include Cruciate Retained, Ultra Congruent/Anterior Stabilized, and Posterior Stabilized options.
 
Christopher C. Reeg, CEO of Fuse commented, “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. 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.”
 
Reeg further stated, “Our priority at Fuse remains to provide innovative solutions for today’s clinical challenges and assist with improving surgical outcomes.”