FDA applicant

Macropore Biosurgery, Inc.

San Diego, CA17 decisions2000–20040 recalls

FDA records 17 decisions for Macropore Biosurgery, Inc. (San Diego, CA) from 2000 to 2004: 17 510(k) clearances. Most are in product codes JEY (Plate, Bone) and HRS (Plate, Fixation, Bone). Its devices cite 17 predicates, 4 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 Macropore Biosurgery, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Macropore Biosurgery, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Macropore Biosurgery, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Macropore Biosurgery, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?