Articles Posted in 510(k) Process

I don’t drink the Kool-Aid. I distrust simple answers, group-think, zealotry. I can’t stand when people make sweeping generalizations about the absolute evil of one side and the unconditional good of the other side. I don’t usually spend much time with plaintiffs’ attorneys who think every corporate decision is an act of violence and malfeasance.…

You have probably seen news reports (or at least the flood of TV commercials from law firms) about the suffering caused by the failure of transvaginal mesh (TVM) products. This is a unique medical device failure “story” because of the large number of women who have been affected. It is estimated that transvaginal mesh is…

“The Most Anatomically Accurate Knee Implant” In 2012, medical device manufacturer Zimmer, Inc. introduced the Persona artificial knee to the public with lofty language. Zimmer announced that the company was “redefining knee arthroplasty and ushering in a new era of personalization with the introduction of the Persona Knee.” Zimmer stated on its website that by…

In the previous post we looked at artificial hips and what should happen before a new medical device product like the Depuy ASR Hip gets to the marketplace. Now, let’s look a little deeper into the Depuy ASR hip system, its metal-on-metal cup and ball design, and how it failed: What is “ASR” anyway? “ASR”…

First, a little history is in order to see how a medical device like a Depuy ASR artificial hip gets to the market (and ultimately, into your body). What is a total hip replacement? A “total hip replacement” replaces the body’s hip joint with an artificial one, and these artificial hips are usually made out…