Copy to clipboard 
FDA granted 510(k) clearance for expanded indications for 3D Systems’ VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform to include skeletally mature adolescents of normal bone stature, in addition to adults.
Key Highlights:
- Immediate commercial acceleration: Eliminates case-by-case compassionate-use approvals and hospital IRB reviews previously required for adolescent patients, streamlining workflows and converting off-label usage into standard, reimbursable procedures at leading centers.
- Targets high-acuity, underserved segment: Over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients under 20. Additional 2,600 primary bone cancer cases in young adults (20–39) are now fully in-scope. Thousands of complex lower-limb osteotomies and reconstructive procedures annually for congenital, developmental, and trauma-related deformities in adolescents.
- Financial Model: VSP Orthopedics cases generate service fees for virtual planning combined with revenue from patient-specific 3D-printed anatomic models and single-use surgical guides produced on 3D Systems’ additive manufacturing platforms. Resulting revenues contribute to the strong, double-digit annual growth rates and highly accretive gross margins associated with 3D Systems’ Med Tech business, according to the company.
- Strengthened competitive moat: 3D Systems is the only provider with FDA-cleared VSP solutions spanning craniomaxillofacial, orthopedics, and now expanded adolescent applications, with a total of over 400,000 total patient-matched cases and devices delivered to date.
- Reimbursement: Procedures covered under existing DRG/CPT codes for tumor resection, osteotomy, and reconstruction—no changes required.
Ben Johnson, Senior Vice President of Medical Technology at 3D Systems, commented, “This regulatory clearance removes a significant friction point for adoption in the pediatric/adolescent orthopedic oncology segment. 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.”
Source: 3D Systems
FDA granted 510(k) clearance for expanded indications for 3D Systems' VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform to include skeletally mature adolescents of normal bone stature, in addition to adults.
Key Highlights:
Immediate commercial acceleration: Eliminates case-by-case compassionate-use...
FDA granted 510(k) clearance for expanded indications for 3D Systems’ VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform to include skeletally mature adolescents of normal bone stature, in addition to adults.
Key Highlights:
- Immediate commercial acceleration: Eliminates case-by-case compassionate-use approvals and hospital IRB reviews previously required for adolescent patients, streamlining workflows and converting off-label usage into standard, reimbursable procedures at leading centers.
- Targets high-acuity, underserved segment: Over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients under 20. Additional 2,600 primary bone cancer cases in young adults (20–39) are now fully in-scope. Thousands of complex lower-limb osteotomies and reconstructive procedures annually for congenital, developmental, and trauma-related deformities in adolescents.
- Financial Model: VSP Orthopedics cases generate service fees for virtual planning combined with revenue from patient-specific 3D-printed anatomic models and single-use surgical guides produced on 3D Systems’ additive manufacturing platforms. Resulting revenues contribute to the strong, double-digit annual growth rates and highly accretive gross margins associated with 3D Systems’ Med Tech business, according to the company.
- Strengthened competitive moat: 3D Systems is the only provider with FDA-cleared VSP solutions spanning craniomaxillofacial, orthopedics, and now expanded adolescent applications, with a total of over 400,000 total patient-matched cases and devices delivered to date.
- Reimbursement: Procedures covered under existing DRG/CPT codes for tumor resection, osteotomy, and reconstruction—no changes required.
Ben Johnson, Senior Vice President of Medical Technology at 3D Systems, commented, “This regulatory clearance removes a significant friction point for adoption in the pediatric/adolescent orthopedic oncology segment. 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.”
Source: 3D Systems
You’ve reached your limit.
We’re glad you’re finding value in our content — and we’d love for you to keep going.
Subscribe now for unlimited access to orthopedic business intelligence.
PM
Patrick McGuire is an ORTHOWORLD Contributor.
