510(k) Report

FDA applicant

Aoi Medical, Inc.

Philedelphia, PA1 decision2012–20120 recalls

FDA records 1 decision for Aoi Medical, Inc. (Philedelphia, PA) in 2012: 1 510(k) clearance. All are in product code NDN (Cement, Bone, Vertebroplasty). 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 Aoi Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Aoi Medical, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aoi Medical, 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?

  • NDNCement, Bone, Vertebroplasty1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K100404Ascendx VCF Reduction SystemAoi Medical, Inc. · 20121cites it

What has FDA decided for it lately?

  • K100404Ascendx VCF Reduction SystemAoi Medical, Inc. · 2012

The one decision as Aoi Medical, Inc. →