Medical device firm Catalyst OrthoScience has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its uncemented Press Fit humeral implant.
Image: Catalyst OrthoScience has announcesd 510(k) clearance for its uncemented Press Fit humeral implant. Photo: courtesy of Business Wire.
The new Press Fit humeral component is a continued evolution of the Catalyst CSR total shoulder system, which is a disruptive technology launched in 2016.
Catalyst is planning a limited market release of the new humeral implant in the coming months.
Featuring a new non-spherical head, the Press Fit humeral implant will help restore the native anatomy of the humeral head and joint kinematics of the shoulder.
Press Fit humeral implant is provided with a titanium plasma spray coating on the bone-facing geometry and uses press-fit fixation for initial stability, enabling to avoid bone cement.
The company will also continue to provide its original cemented humeral component, which is provided with the same ellipsoid head design to replicate the native anatomy.
Catalyst OrthoScience executive chairman and CEO Brian Hutchison said: “Though extensive research studies have demonstrated that the natural shape of the humeral head is non-spherical, most humeral head implants used in total shoulder arthroplasty today remain as spherical surfaces.
“The Catalyst CSR system’s ellipsoid humeral components were specifically designed to mimic the shape of a normal human shoulder. We have seen excellent early clinical results, with the first patients more than two years post-surgery.
“We are excited to now introduce an uncemented version to the original breakthrough Catalyst CSR non-spherical humeral component.”
The Catalyst CSR system is said to facilitate simple surgical technique to create a multi-planer chamfer cut geometry on the humeral head, helping to minimize bone removal and preserve densest bone for the humeral implant fixation.
The patented and angled glenoid instruments assist in the glenoid exposure and reduce retraction on the soft tissue.
The company will exhibit the Press Fit humeral implant at the American Academy of Orthopedic Surgeons (AAOS) 2019 annual meeting in Las Vegas.
Established in 2014, Catalyst OrthoScience is engaged in the development and marketing of advanced surgical implants.