FDA applicant

Isotis Orthobiologics, Inc.

Irvine, CA10 decisions2004–20091 recall

FDA records 10 decisions for Isotis Orthobiologics, Inc. (Irvine, CA) from 2004 to 2009: 10 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and MBP (Filler, Bone Void, Osteoinduction (W/O Human…). Its devices cite 22 predicates, 7 of them its own earlier devices. 1 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 Isotis Orthobiologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Isotis Orthobiologics, 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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Other applicant names beginning “Isotis”

FDA records each applicant name separately; these may or may not be the same firm.

Isotis NV 8

Isotis Orthobiologics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

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What has FDA decided for it lately?

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Other applicant names beginning “Isotis”