3D Systems, Inc.: FDA clearances and approvals
3D Systems, Inc. has 17 FDA 510(k) clearances (first 2016, latest 2026), across 7 product codes in 4 review panels. Median 510(k) review time: 188 days. Since 2017 its median was 158 days, against 130 days for all cleared 510(k)s in the same product codes. It files with the SEC as 3D SYSTEMS CORP (DDD).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 498 |
| 2017 | 1 | 188 |
| 2018 | 0 | — |
| 2019 | 2 | 240 |
| 2020 | 2 | 266 |
| 2021 | 2 | 138 |
| 2022 | 1 | 92 |
| 2023 | 1 | 30 |
| 2024 | 5 | 112 |
| 2025 | 1 | 270 |
| 2026 | 1 | 2 |
Review time against the same product codes
Since 2017, 3D Systems, Inc.'s cleared 510(k)s took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OYK | Ankle Arthroplasty Implantation System | 6 | 6 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 3 | 3 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
| PPT | Cranial Surgical Planning And Instrument Guides | 1 | 1 |
Review panels
- Orthopedic (9)
- Dental (3)
- Radiology (3)
- Neurology (2)
Most recent 3D Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint) | DZJ | 2026-06-03 | 2 |
| K250711 | VSP Orthopedics System | PBF | 2025-12-05 | 270 |
| K243174 | Cadence Ankle PSI System | OYK | 2024-10-25 | 25 |
| K243173 | Salto Talaris Ankle PSI System | OYK | 2024-10-25 | 25 |
| K241326 | Cadence Ankle PSI System | OYK | 2024-08-30 | 112 |
| K241148 | Salto Talaris Ankle PSI System | OYK | 2024-08-30 | 127 |
| K231834 | VSP PEEK Cranial Implant | GWO | 2024-04-04 | 287 |
| K231585 | Vantage PSI System | OYK | 2023-06-30 | 30 |
| K214093 | VSP Bolus | IXI | 2022-03-30 | 92 |
| K211244 | VSP® Orthopedics System | PBF | 2021-11-10 | 198 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 3D Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
3D SYSTEMS CORP (DDD): EDGAR filings, CIK 910638. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does 3D Systems, Inc. have?
3D Systems, Inc. has 17 FDA 510(k) clearances (first 2016, latest 2026), across 7 product codes in 4 review panels.
How long does FDA take to clear 3D Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across 3D Systems, Inc.'s cleared 510(k)s is 188 days. Since 2017: 158 days, versus 130 days for all cleared 510(k)s in the same product codes.
What devices does 3D Systems, Inc. make?
Its most frequent FDA product codes are OYK (Ankle Arthroplasty Implantation System, 6); DZJ (Driver, Wire, And Bone Drill, Manual, 3); PBF (Orthopaedic Surgical Planning And Instrument Guides, 3).
Has 3D Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching 3D Systems, Inc. Related entities may recall under other names.
Next steps
- See all 17 3D Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OYK, 3D Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.