510(k) Report

FDA applicant

Difusion Technologies

Austin, TX3 decisions2010–20190 recalls

FDA records 3 decisions for Difusion Technologies (Austin, TX) from 2010 to 2019: 3 510(k) clearances. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 9 predicates, 2 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 Difusion Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2010: 12013: 12019: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

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

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 20106cite it
  • K123969XiphosDifusion Technologies · 20131cites it

What has FDA decided for it lately?

  • K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies · 2019
  • K123969XiphosDifusion Technologies · 2013
  • K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010

All 3 as Difusion Technologies →