510(k) Report

FDA applicant

OrthoGrid Systems, Inc.

Salt Lake City, UT4 decisions2019–20260 recalls

FDA records 4 decisions for OrthoGrid Systems, Inc. (Salt Lake City, UT) from 2019 to 2026: 4 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 4 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, radiology panel, where it files most

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

FDA decisions per year

1in 2021

2019: 22021: 12026 (partial year): 1
2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — OrthoGrid Systems, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like OrthoGrid 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?

  • LLZSystem, Image Processing, Radiological3decisions
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 122 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 112 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K210136PhantomMSK HipOrthoGrid Systems, Inc. · 20213cite it
  • K182332PhantomMSKOrthoGrid Systems, Inc. · 20192cite it

What has FDA decided for it lately?

  • K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc. · 2026
  • K210136PhantomMSK HipOrthoGrid Systems, Inc. · 2021
  • K192279PhantomMSK TraumaOrthoGrid Systems, Inc. · 2019
  • K182332PhantomMSKOrthoGrid Systems, Inc. · 2019

All 4 as OrthoGrid Systems, Inc. →