510(k) Report

FDA applicant

3D Systems, Inc.

Littleton, CO17 decisions2016–20260 recalls

FDA records 17 decisions for 3D Systems, Inc. (Littleton, CO) from 2016 to 2026: 17 510(k) clearances. Most are in product codes OYK (Ankle Arthroplasty Implantation System) and PBF (Orthopaedic Surgical Planning And Instrument…). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 11 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “3D Systems”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided 3D Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 12019: 22020: 22021: 22022: 12023: 12024: 52025: 12026 (partial year): 1
2016high 5 (2024) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — 3D Systems, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3D Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OYKAnkle Arthroplasty Implantation System6decisions
  • PBFOrthopaedic Surgical Planning And Instrument Guides3decisions
  • DZJDriver, Wire, And Bone Drill, Manual3decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • IXIBlock, Beam-Shaping, Radiation Therapy1decision
  • PPTCranial Surgical Planning And Instrument Guides1decision

Also: GWO (1).

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 127 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 4 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193432Vantage PSI System3D Systems · 20204cite it
  • K190044VSP Orthopedics System3D Systems, Inc. · 20194cite it
  • K211244VSP® Orthopedics System3D Systems · 20213cite it
  • K192192VSP System3D Systems · 20203cite it
  • K161841D2P3D Systems, Inc. · 20172cite it
  • K183489D2P3D Systems, Inc. · 20192cite it

What has FDA decided for it lately?

  • K261826VSP System (Titanium Palatal Splint)3D Systems, Inc. · 2026
  • K250711VSP Orthopedics System3D Systems, Inc. · 2025
  • K243174Cadence Ankle PSI System3D Systems, Inc. · 2024
  • K243173Salto Talaris Ankle PSI System3D Systems, Inc. · 2024
  • K241326Cadence Ankle PSI System3D Systems, Inc. · 2024
  • K241148Salto Talaris Ankle PSI System3D Systems, Inc. · 2024
  • K231834VSP PEEK Cranial Implant3D Systems, Inc. · 2024
  • K231585Vantage PSI System3D Systems, Inc. · 2023

All 12 as 3D Systems, Inc. →All 5 as 3D Systems →