Catalyst OrthoScience has received the US Food and Drug Administration (FDA) 510(k) approval for its Archer 3D Targeting software platform to aid in preoperative planning for shoulder arthroplasty.
Archer 3D Targeting is an advanced, preoperative shoulder planning software that incorporates both anatomic and reverse planning capabilities.
The US medical device maker has licensed the platform technology in partnership with 3D-Shoulder, a subsidiary of Belgium-based medical technology company 3D-Side.
3D-Shoulder has developed the integrated surgical software dedicated to shoulder arthroplasty, connecting surgeons, patients and medical device companies.
It was designed to optimise and simplify communication, creation and supervision of the production of 3D planning and patient-specific medical devices.
Catalyst CEO and president Carl O’Connell said: “We have been working with an excellent group of design surgeons who have worked with Catalyst and 3D-Shoulder to develop the Archer 3D Targeting software.
“We are now initiating a limited user release with a controlled number of shoulder surgeons across the country who will test the software in clinical settings and provide us with feedback prior to a full commercial launch.”
Catalyst said that its Archer 3D Targeting helps shoulder surgeons get better understanding of each patient’s unique pathology.
The software solution helps in delivering a personalised surgical plan to the patients, prior to a procedure, with an aim to improve care.
It leverages two-dimensional imaging, such as CT scan or MRI, which almost all patients would require them before undergoing a shoulder arthroplasty.
Furthermore, Catalyst said that it will commence controlled, limited user release of the planning software to test the platform solution in clinical settings.
The current FDA approval for Archer 3D Targeting closely follows recent FDA marketing approval for Catalyst’s reverse shoulder system.
In May last year, Catalyst completed the first surgeries using its Archer R1 Reverse Shoulder System, a single-tray arthroplasty system.
