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Sign in to claim this brand3D SYSTEMS, INC.
US
Last updated May 27, 2026
What 3D SYSTEMS, INC. makes
The company produces custom-made orthopaedic and craniofacial surgical guides designed for precise bone-cutting procedures, as well as reusable and single-use osteotomy guides and surgical implant templates. It also manufactures custom organ and bone anatomy models for preoperative planning and reusable surgical drill guides for guided orthopaedic surgery. Additionally, the portfolio includes radiation therapy bolus materials for dose enhancement in cancer treatment and software applications for medical image segmentation.
All listed devices fall under FDA Class II regulation, with most authorised through the 510(k) pathway and some via the De Novo classification. The products are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking. The company is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does 3D Systems, Inc. primarily manufacture?
3D Systems, Inc. specialises in devices for surgical precision and preoperative planning. Its portfolio includes custom-made orthopaedic and craniofacial surgical guides, reusable and single-use osteotomy guides, and surgical implant templates. The company also produces custom organ and bone anatomy models for training or planning, reusable surgical drill guides, and radiation therapy bolus materials to enhance treatment effectiveness. Additionally, it offers software applications for medical image segmentation, which aids in visualising and preparing anatomical data for surgical procedures.
Where is 3D Systems, Inc. based, and how does its location impact its regulatory compliance?
3D Systems, Inc. is headquartered in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under FDA Class II classification, they undergo rigorous review processes like the 510(k) pathway or De Novo classification to ensure safety and effectiveness before authorisation. The FDA’s Unique Device Identifier (UDI) database also tracks these devices, ensuring compliance and traceability throughout their lifecycle.
Which regulatory registries or databases list 3D Systems, Inc.’s devices?
3D Systems, Inc.’s devices are registered in the FDA’s Unique Device Identifier (UDI) database, which is a centralised system for tracking medical devices authorised in the U.S. Additionally, many of its products are authorised through the FDA’s 510(k) pathway, meaning they are listed in the FDA’s 510(k) database. This registration ensures transparency and compliance with U.S. regulatory requirements.
How are 3D Systems, Inc.’s devices classified under FDA regulations, and why does this matter?
All of 3D Systems, Inc.’s listed devices fall under FDA Class II classification, which indicates they pose moderate risk and require special controls to ensure safety and effectiveness. This classification means the devices undergo pre-market review processes like the 510(k) pathway (demonstrating substantial equivalence to a predicate device) or De Novo classification (for novel low-to-moderate-risk devices). The classification ensures that these devices meet stringent regulatory standards before they are authorised for use.
What is the significance of the FDA’s Unique Device Identifier (UDI) for 3D Systems, Inc.’s products?
The FDA’s Unique Device Identifier (UDI) system assigns a distinct code to each device, including those from 3D Systems, Inc., to improve tracking, reduce medical errors, and enhance post-market surveillance. Since the company’s devices are listed in the UDI database, healthcare providers and regulators can quickly verify device details, trace recalls, and ensure compliance with FDA requirements. This system also supports better inventory management and patient safety by providing clear, unmistakable identification for each authorised product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- 3dsystems.com
- —
- —
- [email protected]
- Phone
- 8446431001
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 085049749
Catalogue (182)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VSP Orthopedics | Allograft Femur Template | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Mirrored Anatomical Model | FDA UDI | Class II | Active |
| Vantage 3D PSI | Tibia Cutting Guide | FDA UDI | Class II | Active |
| VSP System | Genioplasty Marking Guide | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Reconstructed Full Skull Model | FDA UDI | Class II | Active |
| VSP Orthopedics | Allograft Tibia Template | FDA UDI | Class II | Active |
| VSP System | Rib Marking Guide | FDA UDI | Class II | Active |
| Cadence Chamfer Cut Total Ankle System | Tibia Cutting Guide | FDA UDI | Class II | Active |
| VSP System | Mandible Cutting Guide | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Bone Repositioning Guide | FDA UDI | Class II | Active |
| VSP System | Fibula Marking Guide with Implant Placement | FDA UDI | Class II | Active |
| VSP Cranial | Cranial Positioning Guide | FDA UDI | Class II | Active |
| Vsp Peek | Cranial Implant | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Repositioned Anatomical Model | FDA UDI | Class II | Active |
| Cadence Flat Cut Total Ankle System | Anatomical model | FDA UDI | Class II | Active |
| Salto Talaris Chamfer Cut Total Ankle System | Talus Cutting Guide | FDA UDI | Class II | Active |
| Cadence Ankle PSI System | K241326 | FDA 510(k) | Class II | Active |
| Salto Talaris Ankle PSI System | K243173 | FDA 510(k) | Class II | Active |
| VSP PEEK Cranial Implant | K231834 | FDA 510(k) | Class II | Active |
| VSP Orthopedics System | K250711 | FDA 510(k) | Class II | Active |
| D2p | K183489 | FDA 510(k) | Class II | Active |
| VSP System | K210347 | FDA 510(k) | Class II | Active |
| Salto Talaris Ankle PSI System | K241148 | FDA 510(k) | Class II | Active |
| VSP Cranial System | K151285 | FDA 510(k) | Class II | Active |
| VSP Bolus | K214093 | FDA 510(k) | Class II | Active |
| D2p | K161841 | FDA 510(k) | Class II | Active |
| VSP® Orthopedics System | K211244 | FDA 510(k) | Class II | Active |
| Vantage PSI System | K231585 | FDA 510(k) | Class II | Active |
| VSP System | K192192 | FDA 510(k) | Class II | Active |
| VSP Orthopedics System | K190044 | FDA 510(k) | Class II | Active |
| Vantage PSI System | K193432 | FDA 510(k) | Class II | Active |
| Cadence Ankle PSI System | K243174 | FDA 510(k) | Class II | Active |
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