510(k) Report

FDA applicant

Generation II Orthotics, Inc.

Mchenry, IL1 decision1981–19810 recalls

FDA records 1 decision for Generation II Orthotics, Inc. (Mchenry, IL) in 1981: 1 510(k) clearance. All are in product code ITM (Cage, Knee). 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, physical medicine panel, where it files most

How often FDA has decided Generation II Orthotics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Generation II Orthotics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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