# 3D Systems, Inc.

- Location (FDA's records): Littleton, CO
- FDA decisions: 17 (2016–2026): 17 510(k) clearances
- Names in FDA's records: 3D Systems, Inc. (12); 3D Systems (5)
- Product codes: OYK (6), PBF (3), DZJ (3), LLZ (2), IXI (1), PPT (1), GWO (1)
- 510(k) review time since 2016: median 127 days, against 107 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 17 (11 its own); citations of its devices by later devices: 22 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medical Modeling, Inc.: 2 (https://510kreport.com/company/medical-modeling)
- .Decimal, Inc.: 1 (https://510kreport.com/company/decimal)
- Materialise NV: 1 (https://510kreport.com/company/materialise)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Kelyniam Global, Inc.: 1 (https://510kreport.com/company/kelyniam-global)

## Firms that cite its devices most
- Vha Dean: 2 (https://510kreport.com/company/vha-dean)
- Restor3D: 1 (https://510kreport.com/company/restor3d)
- 3D-Side S.A.: 1 (https://510kreport.com/company/3d-side)
- Mighty Oak Medical, Inc.: 1 (https://510kreport.com/company/mighty-oak-medical)
- Redpoint Medical, LLC: 1 (https://510kreport.com/company/redpoint-medical)
- Coreline Soft Co., Ltd.: 1 (https://510kreport.com/company/coreline-soft)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Lazarus 3D: 1 (https://510kreport.com/company/lazarus-3d)

## Its most-cited devices
- K193432: Vantage PSI System (2020), cited by 4
- K190044: VSP Orthopedics System (2019), cited by 4
- K211244: VSP® Orthopedics System (2021), cited by 3
- K192192: VSP System (2020), cited by 3
- K161841: D2P (2017), cited by 2
- K183489: D2P (2019), cited by 2

## Recent decisions
- K261826: VSP System (Titanium Palatal Splint) (Jun 3, 2026)
- K250711: VSP Orthopedics System (Dec 5, 2025)
- K243174: Cadence Ankle PSI System (Oct 25, 2024)
- K243173: Salto Talaris Ankle PSI System (Oct 25, 2024)
- K241326: Cadence Ankle PSI System (Aug 30, 2024)
- K241148: Salto Talaris Ankle PSI System (Aug 30, 2024)
- K231834: VSP PEEK Cranial Implant (Apr 4, 2024)
- K231585: Vantage PSI System (Jun 30, 2023)

Source page: https://510kreport.com/company/3d-systems