510(k) Report

FDA applicant

Axogen Corporation

Alachua, FL3 decisions2017–20230 recalls

FDA records 3 decisions for Axogen Corporation (Alachua, FL) from 2017 to 2023: 3 510(k) clearances. All are in product code JXI (Cuff, Nerve). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 1 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, neurology panel, where it files most

How often FDA has decided Axogen Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2017: 12023: 2
2017high 2 (2023) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Axogen Corporation by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Axogen Corporation’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?

  • JXICuff, Nerve3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 123 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 122 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector…Axogen Corporation · 20232cite it

What has FDA decided for it lately?

  • K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector…Axogen Corporation · 2023
  • K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector…Axogen Corporation · 2023
  • K163446AxoGen Nerve CapAxogen Corporation · 2017

All 3 as Axogen Corporation →