Fuse Medical, Inc. Announces FDA 510(K) Clearance of the Sterizo™ Tibial Revision Knee System and PS Plus Posterior Stabilized Tibial Insert
August 26, 2021 at 09:00 am EDT
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Fuse Medical, Inc. announced it had received its latest U.S. Food and Drug Administration 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.
Fuse Medical, Inc. is a manufacturer and distributor of medical devices in the United States. The Company provides a range of a portfolio of orthopedic implants, including foot and ankle, orthopedics, sports medicine and spine. It also provides a range of osteo-biologics and regenerative products, which include human allografts, tendons, synthetic skin and bone substitute materials, and regenerative tissues. Its foot and ankle product offerings include internal and external fixation for forefoot, midfoot and hindfoot reconstruction. Its orthopedics offer joint reconstruction systems for upper and lower extremities, which include the sterizo total knee, tibial revision, and total hip replacement systems, as well as the arrow total and reverse total shoulder system. Its sports medicine offers a line of fuse suture anchors and interference screws, as well as multiple products for soft tissue fixation augmentation. Its spine offers spinal products for cervical and thoracolumbar fusion.