510(k) Report

FDA applicant

Medcad

Dallas, TX9 decisions2020–20260 recalls

FDA records 9 decisions for Medcad (Dallas, TX) from 2020 to 2026: 9 510(k) clearances. Most are in product codes PBF (Orthopaedic Surgical Planning And Instrument…) and JEY (Plate, Bone). Since 2016 its 510(k)s took a median of 290 days from receipt to decision, against 263 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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 Medcad’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2020: 12021: 12022: 12023: 32025: 22026 (partial year): 1
2020high 3 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Medcad by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medcad’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?

  • PBFOrthopaedic Surgical Planning And Instrument Guides4decisions
  • JEYPlate, Bone2decisions
  • DZJDriver, Wire, And Bone Drill, Manual2decisions
  • GXNPlate, Cranioplasty, Preformed, Non-Alterable1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 290 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 263 days; 1 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K241811MedCAD® AccuStride™ SystemMedcad · 20252cite it
  • K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad · 20222cite it
  • K192282MedCAD® AccuPlan® SystemMedcad · 20202cite it

What has FDA decided for it lately?

  • K252064MedCAD® AccuStride™ SystemMedcad · 2026
  • K251709MedCAD® AccuStride™ SystemMedcad · 2025
  • K241811MedCAD® AccuStride™ SystemMedcad · 2025
  • K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad · 2023
  • K223421MedCAD AccuPlan Orthopedics SystemMedcad · 2023
  • K223024MedCAD AccuPlan SystemMedcad · 2023
  • K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad · 2022
  • K193280MedCAD® AccuPlate® Patient-Specific PlateMedcad · 2021

All 9 as Medcad →