510(k) Report

FDA applicant

Orthopedic Equipment Co., Inc.

Mchenry, IL45 decisions1976–19840 recalls

FDA records 45 decisions for Orthopedic Equipment Co., Inc. (Mchenry, IL) from 1976 to 1984: 45 510(k) clearances. Most are in product codes JDG (Prosthesis, Hip, Femoral Component, Cemented…) and KNO (Accessories, Wheelchair). 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 Orthopedic Equipment Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthopedic Equipment Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JDGProsthesis, Hip, Femoral Component, Cemented, Metal6decisions
  • KNOAccessories, Wheelchair4decisions
  • GENForceps, General & Plastic Surgery3decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2decisions
  • KWPAppliance, Fixation, Spinal Interlaminal2decisions
  • HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1decision

Also: KWQ (1), IOR (1), KNW (1), HTR (1), HSR (1), GEG (1).

Who builds on its devices?

Later devices cite its devices 13 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 19849cite it
  • K781443Harrington Spine InstrumentationOrthopedic Equipment Co., Inc. · 19782cite it
  • K781448Harrington Hook ClampOrthopedic Equipment Co., Inc. · 19781cites it
  • K781449Harrington Spinal ElevatorOrthopedic Equipment Co., Inc. · 19781cites it

What has FDA decided for it lately?

  • K834035Universal Self-Aligning Acetabular ComOrthopedic Equipment Co., Inc. · 1984
  • K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  • K800530Schlein Tri-Surface AnkleOrthopedic Equipment Co., Inc. · 1980
  • K781445SpreaderOrthopedic Equipment Co., Inc. · 1979
  • K790247Tourniquet Test GageOrthopedic Equipment Co., Inc. · 1979
  • K790209Filter System, Altner DisposableOrthopedic Equipment Co., Inc. · 1979
  • K781447Threaded Rod ClampOrthopedic Equipment Co., Inc. · 1978
  • K781448Harrington Hook ClampOrthopedic Equipment Co., Inc. · 1978

All 45 as Orthopedic Equipment Co., Inc. →