Shanghai, China, 13 June 2023 - Recently, the Syntheface® PEEK Interface Screw Series, a product developed by Suzhou EndoPhix Medical Technology Co., Ltd., an associated company of Shanghai EndoPhix Medical Technology Co., Ltd. (MicroPort® Sports Medicine), has obtained the 510(K) clearance from the U.S. Food and Drug Administration (FDA).
Interface screws are widely used, intra-articular graft fixation devices in sports medicine, commonly employed in cruciate ligament reconstruction procedures. They are indicated to stabilize graft tissues or artificial prostheses with the purpose of achieving a persistent inter-connection with recipient bone, consequently restoring routine activities and physical functions of knee joints.
The Syntheface® PEEK Interface Screw Series, introduced by MicroPort® Sports Medicine, along with its optional fixative wing system, is a standardized solution for single or double bundle reconstruction of Anterior Cruciate Ligament. The medical-grade PEEK material adopted in this product is featured with proved biocompatibility, mechanical strength, an elastic modulus similar to human bone, MRI compatibility, and radiolucency for post-operative observation. The fixative wings are designed to distribute stress radially to the peripheral bone, resulting in an enhanced stability and reduced graft-cutting complications. The external wing produces a 360°-adherence to the tendon to increase tendon-bone healing rate, which is critical to the final success of a cruciate reconstruction. A complete range of specifications in screw diameters ranging from 6mm to 11mm, and in fixation wing diameters ranging from 6mm to 12mm, is offered by MicroPort® Sports Medicine to maximize the operation flexibility under different clinical settings.
MicroPort® Sports Medicine will continue to focus on the needs of frontline clinicians, utilizing product innovation as a driving force to promote the development of soft tissue repair technology and provide high-quality and comprehensive service solutions to the field of sports medicine.