The Gender Solutions(TM) High-Flex Knee, the first knee replacement shaped to fit a woman's anatomy, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The new implant was unveiled today at a joint press conference with one of the surgeon
developers, Robert E. Booth, M.D., Chief of Orthopaedic Surgery at Pennsylvania Hospital, and Zimmer, a worldwide leader in orthopaedics.
Zimmer
Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Senators Question Digital Health Pre-Cert Program
The agency “should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable,” the letter states.
Pfizer Gets FDA Nod for Breast Cancer Drug
The agency based its approval on the results of a 431-patient trial.
FDAnews Device Daily Bulletin
THE SHAPE OF THINGS TO COME: GENDER SOLUTIONS(TM) HIGH-FLEX KNEE IS THE FIRST KNEE REPLACEMENT SHAPED TO FIT A WOMAN'S ANATOMY
May 11, 2006