1. 3D Systems received FDA clearance for adolescent orthopedic procedures. 2. Clearance converts off-label use into reimbursable standard practice. 3. Targets over 1,200 annual new osteosarcoma cases in adolescents. 4. Strengthens financial model through service fees and 3D-printed models. 5. 3D Systems remains the only FDA-approved provider for these applications.
FAQ
Why Very Bullish?
The FDA clearance significantly enhances DDD's market potential, similar to historical cases where FDA approvals led to substantial stock price increases (e.g., after Medtronic's approval of innovative devices).
How important is it?
The article highlights a pivotal regulatory milestone for DDD, indicating substantial future revenue potential and positioning in a niche market.
Why Long Term?
The market expansion for adolescent procedures is expected to sustain demand, similar to long-term growth trends observed post FDA approvals in health tech, which often leads to ongoing revenue streams.
3D Systems Secures FDA Clearance for VSP® Orthopedics, Expanding Services to Adolescents
ROCK HILL, S.C., Dec. 15, 2025 (GLOBE NEWSWIRE) — 3D Systems (NYSE: DDD) has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance, allowing the expansion of its VSP® Orthopedics virtual surgical planning and patient-specific instrumentation platform to include skeletally mature adolescents. This expansion comes in addition to current services for adults, marking a significant milestone for the company.
Key Investment Highlights
- Immediate Commercial Acceleration: The clearance eliminates the need for case-by-case compassionate-use approvals and hospital IRB reviews, streamlining workflows while converting off-label usage into standard, reimbursable procedures.
- High-Acuity Market Target: Approximately 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma occur in patients under 20, with an additional 2,600 primary bone cancer cases in young adults aged 20 to 39 now fully within scope.
- Complex Procedures Addressed: Thousands of complex lower-limb osteotomies and reconstructive surgeries are performed annually for congenital, developmental, and trauma-related deformities in adolescents.
- Strong Financial Model: VSP Orthopedics generates service fees for virtual planning, alongside revenue from patient-specific 3D-printed models and surgical guides, contributing to the strong double-digit growth rates in 3D Systems’ medical technology sector.
- Enhanced Competitive Advantage: As the sole provider of FDA-cleared VSP solutions across craniomaxillofacial, orthopedic, and now expanded adolescent applications, 3D Systems has delivered over 400,000 patient-matched cases to date.
- Favorable Reimbursement Policies: Procedures are already covered under existing DRG/CPT codes for tumor resection, osteotomy, and reconstruction with no additional changes required.
Comments from Leadership
Ben Johnson, Senior Vice President of Medical Technology at 3D Systems, stated, “This regulatory clearance removes a significant friction point for adoption in the pediatric and adolescent orthopedic oncology segment. Surgeons at leading centers have relied on off-label or compassionate-use solutions for years; this decision allows us to convert those cases into routine clinical practices and opens the U.S. adolescent bone sarcoma market to our platform. We are excited to provide these solutions to a broader and underserved patient population.”
Strategic Implications and Future Growth
This regulatory achievement further underscores 3D Systems’ commitment to delivering high-margin personalized healthcare solutions and optimizing its market segments. The expanded indications are expected to provide a meaningful boost for sustaining double-digit average annual growth within the Healthcare segment, facilitated by the accelerated adoption in this high-value market.
About 3D Systems
With nearly four decades of innovation, 3D Systems, founded by Chuck Hull, revolutionized product design and manufacturing through 3D printing. The company continues to partner with customers across various high-value markets, including medical, dental, aerospace, and durable goods. By providing leading 3D printing technologies, materials, and software, 3D Systems aims to transform manufacturing for a better future.
Forward-Looking Statements
This release contains forward-looking statements that may be subject to risks and uncertainties. These statements may deviate from actual results due to various factors detailed in the company’s SEC filings. While management believes that the expectations reflected are reasonable, these forward-looking statements should not be viewed as guarantees of future performance.