510(k) Report

FDA applicant

Kinamed, Inc.

Camarillo, CA35 decisions1988–20181 recall

FDA records 35 decisions for Kinamed, Inc. (Camarillo, CA) from 1988 to 2018: 35 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and HAW (Neurological Stereotaxic Instrument). Its devices cite 17 predicates, 7 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Kinamed, Incorporated”.

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 Kinamed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007: 12011: 12013: 12018: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…12decisions
  • HAWNeurological Stereotaxic Instrument4decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3decisions
  • JDQCerclage, Fixation3decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented3decisions
  • KWLProsthesis, Hip, Hemi-, Femoral, Metal2decisions

Also: KRR (1), KWA (1), LPH (1), DZL (1), HRS (1), MEH (1).

Whose devices does it build on?

Its devices cite 17 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 7 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.

  • K003347OrthopilotKinamed, Inc. · 20019cite it
  • K994214Gem Knee SystemKinamed, Inc. · 20005cite it
  • K030256Iso-Elastic Cerclage SystemKinamed, Inc. · 20032cite it
  • K010101Gem Posterior Stabilized Total Knee SystemKinamed, Inc. · 20012cite it
  • K102834Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)Kinamed, Incorporated · 20111cites it
  • K181749SuperCable® Iso-Elastic™ Cerclage SystemKinamed, Incorporated · 20181cites it

What has FDA decided for it lately?

  • K181749SuperCable® Iso-Elastic™ Cerclage SystemKinamed, Incorporated · 2018
  • K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc. · 2013
  • K102834Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)Kinamed, Incorporated · 2011
  • K072250Supercable Grip and Plate SystemKinamed, Inc. · 20071 recall
  • K050897Navipro Shoulder Software ModuleKinamed, Inc. · 2005
  • K033668Navipro Knee Software ModuleKinamed, Inc. · 2004
  • K032950Gem Inset Patellar ComponentKinamed, Inc. · 2003
  • K030256Iso-Elastic Cerclage SystemKinamed, Inc. · 2003

All 33 as Kinamed, Inc. →All 2 as Kinamed, Incorporated →

What has been recalled?

1 recall linked to its devices; the latest:

  • K072250Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060…Aug 18, 2010