Food and Drug Administration Safety and Innovation Act Signed

July 9, 2012

Contact: HHS Press Office
(202) 690-6343

Statement from HHS Secretary Kathleen Sebelius on the signing of the Food and
Drug Administration Safety and Innovation Act

Today, the President signed into law S. 3187, the “Food and Drug Administration
Safety and Innovation Act.” This legislation, which passed both the House and
Senate with overwhelming bipartisan majorities, will help speed safe and
effective medical products to patients and maintain our Nation’s role as a
leader in biomedical innovation.

S. 3187 is the culmination of the work of the administration and Congress, in
partnership with patients, the … Read the rest

Biomet Hip Resurfacing System Clinical Trial

Biomet Hip Resurfacing System Clinical Trial

April 10, 2012 in Hip Implants

The Biomet Hip Resurfacing System clinical trial has been approved by the FDA to determine if the Biomet total resurfacing system is safe and a viable alternative to total hip replacement surgery. The FDA protocol determines which patients may be eligible to take part in the study. The FDA also requires that doctors participating in this study be approved by the Institutional Review Board (IRB) for the Protection of Human Subjects. Currently, only one doctor located in New Jersey or Pennsylvania has been approved to participate in this … Read the rest

New FDA Guidance used in Device Approval

For Immediate Release: March 27, 2012
Media Inquiries: Michelle Bolek, 301-796-2973,
Consumer Inquiries: 888-INFO-FDA

New FDA guidance on considerations used in device approval, de novo decisions
Clinical data, risks, benefits and patient risk tolerance outlined in process

The U.S. Food and Drug Administration today published a first-of-a-kind
guidance1 for medical device manufacturers, describing how the benefits and
risks of certain medical devices are considered during pre-market review.… Read the rest

FDA To Discuss Risks/Benefits MOM Hip Devices

For Immediate Release: March 29, 2012
Media Inquiries: Michelle Bolek, 301-796-2973,
Consumer Inquiries: 888-INFO-FDA

FDA to discuss risks and benefits of metal-on-metal hip replacements
Expert, patient recommendations being sought

The U.S. Food and Drug Administration today announced that it is seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems as well as potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with such devices. FDA will discuss these issues at a two-day expert advisory panel meeting1 on June 27-28, 2012.… Read the rest

ASR Recall by DePuy 2010

DePuy has announced that it is voluntarily recalling the
ASR™ XL Acetabular Head System and DePuy ASR™ Hip
Resurfacing System. DePuy is providing the information
below to help visitors with questions and concerns.
Visitors are also invited to visit the DePuy website at


  • DePuy makes patient safety and health a top priority
    and is continually evaluating data about its
    products. Most ASR hip replacement surgeries have
    been successful. However, data recently received by
    the company shows that more people than expected who
    received the ASR hip experienced pain and other
    symptoms that lead to a second hip replacement
Read the rest

Wright Medical Group, Inc. Receives FDA Approval to Market Conserve Plus Total Hip Resurfacing System

ARLINGTON, Tenn.-(BUSINESS WIRE) – Nov. 9, 2009 – Wright
Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic
medical device company, announced today that the United
States Food and Drug Administration (FDA) has given approval
to the Company to market its original CONSERVE® Plus Total
Hip Resurfacing System. Now available in the United States,
this innovative total surface arthroplasty system provides
surgeons and their patients a bone-conserving alternative to
traditional total hip replacement.

The approval permits Wright to market CONSERVE® Plus in the
original femoral and acetabular component configuration
specified in its PreMarket Approval (PMA) application and
enables the Company to … Read the rest

FDA wants surveillance net for orthopedic devices

By Peter Buxbaum 
Published on August 4, 2008

The Food and Drug Administration has proposed a
program that would query public and private databases to help study the efficacy
of orthopedic implants.

FDA will issue a request for quotations next month in an effort to identify
companies that could evaluate orthopedic implant registries for participation in
the program.

The program is part of the broader Sentinel Initiative FDA launched earlier this
year. The broader effort is intended to monitor and provide early warnings of
potential problems with FDA-approved medical products.

The implant program would “create a national network of registries … Read the rest

Stryker Statement Regarding FDA Warning Letter


Stryker Issues Statement Regarding FDA Warning Letter

KALAMAZOO, Mich., Jan. 22 /PRNewswire-FirstCall/ — Stryker Corporation (NYSE:
SYK) today issued the following statement in response to recent media attention
regarding a Warning Letter dated November 28, 2007, that the United States Food
and Drug Administration (FDA) published on its web site on January 15, 2008.

While Stryker does not normally comment on discussions with the FDA, the Company
believes it is obligated to provide additional information to healthcare
professionals, providers and patients in light of several media reports that
draw erroneous conclusions surrounding the Warning Letter.

Most importantly, the … Read the rest

First FDA Approved Cormet Hip Resurfacing Performed

First Post-FDA Approved Stryker Cormet™ Hip Resurfacing Procedure


By Walter Eisner November 7, 2007

Orville Todd is the first person in the U.S. to undergo Stryker’s Cormet Hip
Resurfacing procedure since the FDA approved the procedure last summer.

The procedure was performed by Richard A. Conn, M.D., an orthopedic surgeon with
Southern Bone & Joint Specialists in Hattiesburg, Mississippi.

Todd, 60, said, “I had hip pain for about five years, and it just kept getting
worse. Finally it got to the point where I couldn’t stand it anymore. It made my
job difficult—the longer the day went, … Read the rest