The U.S. Food and Drug Administration granted 510(k) clearance to 3D Systems’ VSP® Orthopedics platform for skeletally mature adolescents, extending the device’s use beyond adults.
The clearance comes after the company’s Healthcare Solutions segment reported a 22% year‑over‑year decline in revenue in Q3 2025 and a 21% decline in Q4 2024, underscoring the need for new growth drivers.
The adolescent market includes more than 1,200 U.S. cases of osteosarcoma and Ewing sarcoma each year, an additional 2,600 primary bone cancer cases in young adults, and thousands of complex lower‑limb reconstructive procedures, creating a sizable underserved opportunity.
3D Systems is the only firm with FDA‑cleared VSP solutions that span craniomaxillofacial, orthopedics, and now adolescent applications, and it has delivered over 400,000 patient‑matched cases to date.
Ben Johnson, senior vice president of medical technology, said the clearance removes a major friction point for adoption in the pediatric and adolescent orthopedic oncology segment and opens the U.S. adolescent bone sarcoma and deformity market to the platform.
By eliminating the need for case‑by‑case compassionate‑use approvals and institutional review board reviews, the clearance converts off‑label uses into standard, reimbursable procedures, positioning the platform to contribute to the company’s high‑margin healthcare business.
The approval is expected to accelerate double‑digit growth in the Healthcare segment, strengthen the company’s competitive moat, and support its strategic focus on high‑margin medical technology solutions.
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