3D Systems, a leading additive manufacturing company based in Rock Hill, South Carolina, announced on December 15, 2025, that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This regulatory approval expands the indications for its VSP® Orthopedics platform to include skeletally mature adolescents of normal bone stature, in addition to adults.
This significant advancement addresses a crucial gap in the market for pediatric and adolescent orthopedic oncology. According to Ben Johnson, senior vice president of medical technology at 3D Systems, the clearance alleviates a major barrier for surgeons who have relied on off-label or compassionate use solutions for these patients. He stated, “This decision immediately converts those cases into routine clinical practice and opens the U.S. adolescent bone sarcoma and deformity market to our platform.”
The VSP® Orthopedics platform allows for virtual surgical planning and patient-specific instrumentation, enabling tailored solutions for complex orthopedic procedures. By including adolescents in its indications, 3D Systems aims to provide enhanced options for an underserved patient population, ultimately improving surgical outcomes.
Impact on Healthcare Sector
This regulatory milestone aligns with 3D Systems’ ongoing commitment to high-margin personalized healthcare solutions. The company anticipates that this expanded indication will contribute to sustained double-digit average annual growth within its healthcare segment. The accelerated adoption of these advanced solutions in a high-value market underscores 3D Systems’ strategic focus on optimizing its offerings.
3D Systems has been a pioneer in 3D printing technologies for nearly 40 years. Founded by Chuck Hull, the company has continuously evolved, delivering cutting-edge solutions across various industries, including medical, aerospace, and automotive sectors. The recent FDA clearance marks a pivotal moment in the company’s history, reinforcing its role as a leader in innovative healthcare solutions.
As the landscape of orthopedic surgery evolves, the inclusion of pediatric applications in 3D Systems’ offerings could significantly enhance treatment options. This move not only benefits healthcare providers but also holds the potential for improved patient experiences and outcomes.
3D Systems is committed to transforming the manufacturing process for a better future. By leveraging its expertise in 3D printing, the company strives to meet the diverse needs of its clients and the patients they serve.
Forward-Looking Statements
Certain statements in this announcement may be classified as forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from expectations. Factors that could affect outcomes include market conditions, regulatory changes, and other variables outside the company’s control.
While management believes that the expectations reflected in these statements are reasonable, they should not be regarded as guarantees of future performance. 3D Systems does not undertake any obligation to update or review forward-looking statements following their initial release.
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