FDA applicant

Bone Solutions, Inc.

Colleyville, TX9 decisions2009–20260 recalls

FDA records 9 decisions for Bone Solutions, Inc. (Colleyville, TX) from 2009 to 2026: 9 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 102 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 8 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 Bone Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009high 2 (2022) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Bone Solutions, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bone Solutions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Bone”

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

Bone Index Finland, Ltd. 3 Bone Anchorage Systems, Inc. 1 Bone Health Technologies, Inc. 1

Bone Solutions, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

Other applicant names beginning “Bone”