510(k) Report

FDA applicant

Simplicity Orthopedic Solutions, LLC

North Andover, MA1 decision2004–20040 recalls

FDA records 1 decision for Simplicity Orthopedic Solutions, LLC (North Andover, MA) in 2004: 1 510(k) clearance. All are in product code HWC (Screw, Fixation, Bone). 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 Simplicity Orthopedic Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Simplicity Orthopedic Solutions, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Simplicity Orthopedic Solutions, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Simplicity”

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