510(k) Report

FDA applicant

Cardo Medical Corp.

Clifton, NJ5 decisions2009–20100 recalls

FDA records 5 decisions for Cardo Medical Corp. (Clifton, NJ) from 2009 to 2010: 5 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LZO (Prosthesis, Hip, Semi-Constrained…). Its devices cite 15 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cardo Medical, Inc.”.

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 Cardo Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2010

2009: 22010: 3
2009high 3 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

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

Planning a device like Cardo Medical Corp.’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

Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision

Whose devices does it build on?

Its devices cite 15 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 20091cites it
  • K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp. · 20101cites it

What has FDA decided for it lately?

  • K101032Cardo Medical Femoral Cement Restrictor, Model 503-MCRXCardo Medical, Inc. · 2010
  • K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc. · 2010
  • K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp. · 2010
  • K092803Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp. · 2009
  • K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009

All 3 as Cardo Medical Corp. →All 2 as Cardo Medical, Inc. →