510(k) Report

FDA applicant

Ouroboros Medical

Fremont, CA3 decisions2012–20161 recall

FDA records 3 decisions for Ouroboros Medical (Fremont, CA) from 2012 to 2016: 3 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and HRX (Arthroscope). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Ouroboros Medical, Inc.”.

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 Ouroboros Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12014: 12016: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2012high 1 (2018) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Ouroboros Medical by year, 2012–2026Sources: 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, Lumbar2decisions
  • HRXArthroscope1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K133514Xcage Interbody Fusion SystemOuroboros Medical · 20143cite it
  • K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc. · 20162cite it
  • K122861XTOOLOuroboros Medical · 20121cites it

What has FDA decided for it lately?

  • K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc. · 20161 recall
  • K133514Xcage Interbody Fusion SystemOuroboros Medical · 2014
  • K122861XTOOLOuroboros Medical · 2012

All 2 as Ouroboros Medical →The one decision as Ouroboros Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K160076FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System)…Feb 27, 2018Class II