510(k) Report

FDA applicant

Augmenix, Inc.

Waltham, MA5 decisions2013–20192 recalls

FDA records 5 decisions for Augmenix, Inc. (Waltham, MA) from 2013 to 2019: 4 510(k) clearances and 1 De Novo grant. Most are in product codes OVB (Hydrogel Spacer) and NEU (Marker, Radiographic, Implantable). Its devices cite 5 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

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

FDA decisions per year

1in 2019

2013: 12015: 22018: 12019: 1
2013high 2 (2015) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

2in 2022

2022: 2
2013high 2 (2022) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Augmenix, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Augmenix, 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?

  • OVBHydrogel Spacer3decisions
  • NEUMarker, Radiographic, Implantable2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 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.

  • DEN140030SpaceOAR SystemAugmenix, Inc. · 20153cite it
  • K182971SpaceOAR Vue HydrogelAugmenix, Inc. · 20192cite it
  • K181465SpaceOAR SystemAugmenix, Inc. · 20182cite it

What has FDA decided for it lately?

  • K182971SpaceOAR Vue HydrogelAugmenix, Inc. · 20191 recall
  • K181465SpaceOAR SystemAugmenix, Inc. · 20181 recall
  • K151998TraceIT Tissue Marker - 3mLAugmenix, Inc. · 2015
  • DEN140030SpaceOAR SystemAugmenix, Inc. · 2015
  • K121964Markit Tissue Marker-1ML Markit Tissue Marker-3ML Markit Tissue Marker-10MLAugmenix, Inc. · 2013

All 5 as Augmenix, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K182971SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior…Feb 24, 2022Class II
  • K181465SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily…Feb 24, 2022Class II