US-based medical technology company MedCAD has secured the US Food and Drug Administration (FDA) 510(k) clearance for its AccuStride Foot and Ankle System.
The AccuStride System is designed to enhance outcomes in proximal phalanx and metatarsal arthroplasty procedures.
It also offers custom solutions for Lapidus revisions and cavus foot corrections.
The patient-specific device, coupled with the company’s in-house software, aims to assist surgeons in addressing multiple pathologies in a single procedure.
MedCAD CEO and president Nancy Hairston said: “MedCAD’s newly announced, patient-matched solution is unlike anything else available for surgeons who routinely perform complex or revision cases in the treatment of the entire foot.
“We have experienced a surge in inquiries and interest from leading foot and ankle orthopaedic specialists who are eager to use our ‘whole foot’ solutions for multiple pathologies, and we expect these custom 3D printed devices to reduce the frequency and duration of surgeries, and to deliver high-quality, durable outcomes.”
The AccuStride System represents MedCAD’s first venture into lower extremity solutions, and is suitable for patients aged 12 and older.
Constructed from UV-curable acrylate polymers or titanium alloy, the AccuStride System’s components can be delivered within five days following medical imaging and surgeon design approval.
The FDA approval facilitates the company’s entry into the foot and ankle market.
MedCAD specialises in creating customised surgical guides, designed one patient at a time, based on individual scan data and surgeon input.
The company employs 3D CAD software for virtual surgical planning, allowing for precise simulation and design of custom surgical solutions.
It also manufactures patient-specific, custom-designed cranial and maxillofacial reconstruction implants, including virtual planning and surgical devices.
Hairston added: “The goal of MedCAD’s portfolio of patient-matched product solutions is to provide surgeons with customisable options that are as anatomically unique as their patients.
“MedCAD has been building a strong reputation for putting cutting-edge planning technology into the hands of surgeons so that they can deliver life-changing outcomes for the people they heal.
“With AccuStride, we recognised that when one part of a foot is experiencing problems, significant issues can show up in other areas as well, and with our advanced, wholistic approach, the outcomes are unmatched, and the possibilities are virtually endless.”
