FDA clears Onkos Surgical’s 3D-printed pelvic reconstruction implants
The field of medicine has moved into a new dimension in recent years as 3D printing technology has become more accurate and been adapted to work with biocompatible and biological materials that can be shaped into implants, drugs, scar tissue and even replacement organs.
And though it may be a while before hospitals are able to print out new hearts or lungs on demand, many have already introduced 3D-printed implants into their surgical practices. These devices are personalized to each patient’s specific anatomy, all but guaranteeing a perfect fit in knee and hip replacement, spinal fusion and other orthopedic procedures.
A system newly cleared by the FDA brings that accuracy to the creation of implants for pelvic reconstruction surgeries. Onkos Surgical’s My3D personalized pelvic reconstruction system aims to help surgeons more easily navigate the challenges associated with the procedure, a major surgery that requires implants to be attached to both bone and soft tissue.
The My3D system combines technologies for both planning and carrying out surgical procedures. Surgeons begin by uploading patient scans to Onkos’ cloud-based uDesign portal, where they’re rendered into 3D models. Using those models, doctors can plan out the procedure and design implants that’ll be 3D-printed to fit precisely into the patient’s individual anatomy.
In total, the process takes about six weeks, from the earliest stages of planning to the production of surgery-ready implants.
The latest version of Onkos’ My3D software is meant to help craft 3D-printed implants for both acetabular and advanced reconstruction procedures spanning 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,” Matthew Seidel, M.D., an Arizona-based orthopedic surgeon, said in a statement. “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.”
The FDA’s green light for Onkos to begin its U.S. rollout of the new My3D system comes as the New Jersey-based company is working on expanding its portfolio through other avenues.
Last month, it inked an agreement with Stryker to acquire the medtech giant’s Juvenile Tumour System, an implanted prosthesis that can be lengthened over time without requiring follow-up surgeries. The device is meant to support limb stabilization and growth in children with bone cancers, severe arthropathy, severe trauma and other conditions requiring limb reconstruction.
That deal, in turn, came a few months after Onkos reeled in $15 million in series C funding, which it said would go toward expanding the company’s R&D pipeline, commercial footprint and manufacturing capabilities.
