3D Systems has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its VSP® Orthopedics virtual surgical planning and patient-specific instrumentation platform. This expansion allows the platform to be used for skeletally mature adolescents of normal bone stature, in addition to its existing indications for adults.
The announcement, made on December 15, 2025, represents a significant development in the field of pediatric orthopedic oncology. According to Ben Johnson, senior vice president of medical technology at 3D Systems, this regulatory clearance removes a substantial barrier to adoption in this specialized segment. He noted, “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.”
This regulatory approval aligns with 3D Systems’ strategy to focus on high-margin personalized healthcare solutions as part of their ongoing efforts to optimize the healthcare segment. The company anticipates that expanding its indications will contribute to sustaining double-digit average annual growth in this area, supported by accelerated adoption in a high-value market.
The VSP® Orthopedics platform has been designed to enhance surgical outcomes by offering tailored solutions for individual patients. With this new clearance, 3D Systems is positioned to better serve an expanded and underserved patient population.
Founded nearly 40 years ago by Chuck Hull, 3D Systems pioneered the 3D printing industry and has since evolved into a full-service solutions partner. The company provides industry-leading 3D printing technologies, materials, and software across various sectors, including medical and dental, aerospace, and durable goods.
As the landscape for medical technology continues to evolve, 3D Systems remains committed to innovating and adapting its offerings to meet the needs of diverse patient populations.
This recent FDA clearance not only underscores the importance of personalized healthcare but also reflects a growing recognition of the need for advanced solutions in pediatric care. As 3D Systems continues to expand its capabilities, it is likely to play a critical role in shaping the future of orthopedic surgery for young patients.
For more information, interested parties can contact the company through its investor relations or media contacts.
