510(k) Report

FDA applicant

Allosource, Inc.

Centennial, CO4 decisions2008–20231 recall

FDA records 4 decisions for Allosource, Inc. (Centennial, CO) from 2008 to 2023: 4 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). 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 “Allosource”.

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 Allosource, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12011: 12018: 12023: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2008high 1 (2014) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Allosource, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Allosource, 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?

  • MQVFiller, Bone Void, Calcium Compound2decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene2decisions

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 3 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.

  • K170957ReConnex Pre-Sutured TendonAllosource · 20182cite it
  • K071849Allofuse Gel and PuttyAllosource, Inc. · 20081cites it

What has FDA decided for it lately?

  • K213046AceConnex Pre-Sutured FasciaAllosource · 2023
  • K170957ReConnex Pre-Sutured TendonAllosource · 2018
  • K103036Allofuse PlusAllosource, Inc. · 2011
  • K071849Allofuse Gel and PuttyAllosource, Inc. · 20081 recall

All 2 as Allosource, Inc. →All 2 as Allosource →

What has been recalled?

1 recall linked to its devices; the latest:

  • K071849AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic…Mar 25, 2014Class II