Rock Hill, S.C.-based 3D Systems received FDA 510(k) clearance to expand its VSP Orthopedics platform for use in skeletally mature adolescents with normal bone stature.
The clearance eliminates the need for compassionate-use or institutional review board approvals in adolescent cases, enabling standard, reimbursable care, according to a Dec. 15 news release.
VSP Orthopedics aims to support the more than 1,200 annual U.S. cases of osteosarcoma and Ewing sarcoma in patients under 20, according to data from the American Cancer Society, plus 2,600 bone cancer cases in young adults and adolescent deformity reconstructions.
3D Systems has delivered over 400,000 patient-matched cases and remains the only FDA-cleared provider of virtual surgical planning across craniomaxillofacial, orthopedic and adolescent uses.
The company said procedures are covered under existing CPT and DRG codes and expects the clearance to support continued double-digit growth in its medtech segment, according to the release.
