Picture: 3D Systems
3D Systems reports an expanded FDA 510(k) clearance for its VSP Orthopedics platform. The indication now includes, in addition to adults, skeletally mature adolescents with normal bone anatomy. For clinics and medical technology providers, this is particularly relevant because patient-specific 3D-printed components can now be used more often as a standard, reimbursable treatment option.
VSP Orthopedics combines virtual surgical planning with patient-specific instrumentation. Typically, segmented CT or MRI data are used to create a 3D model on which resection lines, osteotomies, and reconstruction steps are defined digitally. From this, the system derives anatomical 3D models as well as single-use surgical guides that are manufactured on additive production systems. Such guides serve in the OR as a mechanical reference to implement saw cuts or drill channels with reproducible geometry and to align implant positions more closely with the preoperative plan.
Ben Johnson, senior vice president of medical technology at 3D Systems commented, “This regulatory clearance removes a significant friction point for adoption in the pediatric/adolescent orthopedic oncology segment. Surgeons at leading centers have been using off-label or compassionate use solutions for years; this decision immediately converts those cases into routine clinical practice and opens the U.S. adolescent bone sarcoma and deformity market to our platform. We are thrilled to now offer these solutions to an expanded and underserved patient population.”
From the manufacturer’s perspective, the business model remains two-pronged: fees for the planning service are complemented by revenue from printed models and patient-specific guides. With the expanded indication, 3D Systems is targeting complex cases in orthopedic oncology and reconstructive surgery in particular, where precise cutting guidance and short iterative surgical loops are clinically and economically meaningful.
