SimpliFix Receives FDA 510(k) Clearance

Exton, Penn., April 19, 2023 – Today, Stabiliz Orthopaedics announced that its SimpliFix Hip System received U.S. Food and Drug Administration (FDA) 510(k) clearance.

SimpliFix is a revolutionary fixation device for use with intracapsular femoral neck (hip) fractures. The technology aims to reduce the incidence of complications that other devices and techniques have failed to address.

Utilizing surgeon-controlled compression, the system aims to resist femoral neck shortening. Maintaining the patient’s natural anatomy and preserving femoral neck length has been shown to improve postoperative pain and functional outcomes. Using a novel cross-screw technique, SimpliFix minimizes rotation of the femoral head. Maintaining rotational stability is a critical factor in preventing displacement and subsequent femoral neck shortening.

More on the SimpliFix Hip System can be found here.

About Stabiliz Orthopaedics:

Stabiliz Orthopaedics, Inc is a medical device innovator that designs and commercializes creative orthopaedic trauma implants. Passionate about improving patient outcomes by improving clinical options, Stabiliz partners with world-renowned surgeons who have a vision to make a difference.

SimpliFix demonstrated an enhanced ability to maintain femoral neck length, while limiting femoral head rotation in preclinical testing. In vitro studies may not be representative of clinical performance.

 Learn more about StabilizOrtho and SimpliFix at www.stabilizortho.com