Onkos Surgical announced today that the FDA has cleared its My3D personalized pelvic reconstruction system.
My3D expands Onkos Surgical’s portfolio to include systems to treat pelvic conditions.
The Parsippany, New Jeresey–based company said My3D includes 3D-printed implants, instruments and models. There is also an advanced planning service to treat deformity, trauma, disease and revisions. There are patient-specific implants for both acetabular reconstruction and advanced reconstruction that span multiple regions of the pelvis.
“Patients with these conditions of the pelvis have many clinical challenges. Historically, our implant options are mass-produced and may not be best suited for the individuality that each patient requires. With this platform, Onkos has developed a process that allows me to virtually plan the surgery in advance and delivers a patient-specific implant and instruments in a matter of weeks. It changes the way I can treat my patients,” Dr. Matthew Seidel, an orthopedic surgeon with HonorHealth Orthopedics in Scottsdale, Arizona, said in a news release.
The My3D service includes access to the Onkos uDesign digital ecosystem that enables surgeons to send patient images through a secure, HIPAA-compliant, cloud-based portal. Onkos’ uDesign turns anatomical images into 3D models for use in virtual surgical planning sessions.
Onkos officials say the new 510(k) clearance means they can meet surgery requirements in 6 weeks from start to finish.
Onkos Surgical co-Founder and CEO Patrick Treacy said: “This clearance is a major milestone for Onkos Surgical as we continue to leverage our experience and expertise in 3D planning and printing to optimize patient-specific solutions for complex orthopaedic conditions. We founded the company with the belief that patients with these challenging conditions deserve solutions designed specifically for them. Our My3D platform and digital ecosystem enable us not only to provide that personalized solution faster, but also to lay the foundation for future clearances in musculoskeletal personalization.”