510(k) Report

FDA applicant

Biogennix, LLC

Irvine, CA9 decisions2010–20240 recalls

FDA records 9 decisions for Biogennix, LLC (Irvine, CA) from 2010 to 2024: 9 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and OVD (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biogennix”.

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

FDA decisions per year

1in 2024

2010: 12014: 12015: 22018: 12019: 12020: 22024: 1
2010high 2 (2015) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Biogennix, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biogennix, LLC’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?

  • MQVFiller, Bone Void, Calcium Compound7decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 104 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 114 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 7 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K093342Biogennix RPCBiogennix, LLC · 20102cite it
  • K142828osteoSPAN MorpheusBiogennix · 20152cite it
  • K132377Osteospan MorpheusBiogennix, LLC · 20142cite it
  • K141798Sypher Spacer SystemBiogennix, LLC · 20151cites it

What has FDA decided for it lately?

  • K240621Morpheus® Moldable; Agilon® MoldableBiogennix, LLC · 2024
  • K193487Agilon StripBiogennix, LLC · 2020
  • K193168Agilon MoldableBiogennix, LLC · 2020
  • K190371Morpheus-CBiogennix, LLC · 2019
  • K181337Sypher Spacer SystemBiogennix, LLC · 2018
  • K141798Sypher Spacer SystemBiogennix, LLC · 2015
  • K142828osteoSPAN MorpheusBiogennix · 2015
  • K132377Osteospan MorpheusBiogennix, LLC · 2014

All 8 as Biogennix, LLC →The one decision as Biogennix →