The company said that the My3D Personalised Pelvic Reconstruction system is a first-of-its-kind treatment for deformity, trauma, illness, and revisions when other treatments or revisions have failed
Onkos Surgical has received FDA 510(k) clearance for its My3D Personalized Pelvic Reconstruction system. (Credit: Lutz Peter from Pixabay)
Surgical oncology company Onkos Surgical has received the US FDA 510(k) clearance for its My3D Personalised Pelvic Reconstruction system.
According to the firm, the My3D Personalised Pelvic Reconstruction system is a first-of-its-kind treatment for deformity, trauma, illness, and revisions when other treatments or revisions have failed.
It comprises 3D printed implants, tools, and models in addition to an advanced planning service.
The product line also includes acetabular reconstruction and advanced pelvic reconstruction implants for multiple regions of the pelvis.
The implants are created and printed with special characteristics that aid in overcoming the difficulties of soft tissue and bone attachment and anatomical restoration precision.
Through the My3D service, a surgeon can access Onkos uDesign Digital Ecosystem to send patient images through a secure, HIPAA compliant, cloud-based portal.
The anatomical photographs are then turned into 3D models for the surgeon to work together virtually on surgical planning for the removal of the damaged bone and for the implant that perfectly suits the patient.
With the FDA’s authorisation and capacity, Onkos can complete the surgical criteria in six weeks.
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 optimise 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 personalised solution faster, but also to lay the foundation for future clearances in musculoskeletal personalisation.”
The company said over 350 medical centres in the US have selected its advanced Precision Orthopaedics systems.
The system offers enhanced patient outcomes and experiences utilising the most recent advancements in virtual surgical planning, 3D anatomic modelling and printing, implant design, and workflow optimisation.