Category Archives: FDA Approvals

Polymotion IDE Study Locations

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We are excited to announce the recent launch of our IDE Study for the Polymotion® Hip Resurfacing Device. The IDE study aims to evaluate the safety and clinical effectiveness of the Polymotion® Hip Resurfacing System. ​There are currently nine sites in the USA and one international site in Bermuda participating. … Continue reading →

FDA Approved Hip Resurfacing Devices

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Updated 2014 FDA Approved Hip Resurfacing Devices BHR – Birmingham Hip Resurfacing System by Smith & Nephew   Dr.Pritchett Explains Metal Free Cementless Hip Resurfacing Device 2014 (Synovo Preserve) Corin Cormet Hip Resurfacing Device withdrawn from US Market 2013 Wright Medical Conserve Plus Hip Resurfacing Device withdrawn from US Market 2014 Continue reading →

FDA Approvals by Dr. Gross

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The Birmingham (Smith & Nephew, Richards) total HSR was the first to get FDA approval in the US based on an unprecedented FDA decision to approve this implant on the basis of single (developing) surgeon’s foreign data. Cormet 2000 ( Corin Ltd., Stryker) total HSR was the first to be approved based on the usual… Continue reading →

FDA to Stryker: Fix hip implant flaws

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  FDA to Stryker: Fix hip implant flaws Link to Original Article SNBC  By LINDA A. JOHNSON updated 5:48 p.m. ET, Wed., Jan. 16, 2008 TRENTON, N.J. – Federal regulators have ordered medical device maker Stryker Corp. to fix a host of long-standing problems in its manufacturing of hip replacement parts that have triggered multiple… Continue reading →

FDA to collect adverse event data 2011

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Updated 3/21/2011 U.S. FDA to Collect Adverse Event Data Despite UK Recall of Metal Hip Implants http://fdanews.com/newsletter/article?issueId=14568&articleId=135224 Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the U.S. Food and Drug Administration (FDA) says. National Joint Registry of England and… Continue reading →

FDA Safety Communication: Metal-on-Metal Hip Implants

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Updated 4/22/2013 Date Issued: Jan. 17, 2013 Audience: Orthopaedic surgeons Health care providers responsible for the ongoing care of patients with metal-on-metal hip implants Patients who are considering or have received a metal-on-metal hip implant Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors Device: Metal-on-metal hip implants… Continue reading →

FDA Approvals and Information About Off Label Hip Resurfacing Systems by Dr. Gross

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Updated 4/22/2013   FDA Proposing Premarket Approval Application for Metal on Metal Devices 2013 FDA Safety Communication: Metal-on-Metal Hip Implants 2013 Questions I should ask my orthopaedic surgeon about metal-on-metal hip implants by the FDA Wright Medical Group, Inc. Receives FDA Approval to Market CONSERVE® Plus Total Hip Resurfacing System FDA Approval of BHR -… Continue reading →

FDA wants surveillance net for orthopedic devices

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Updated 8/5/08 Link  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… Continue reading →

Food and Drug Administration Safety and Innovation Act Signed

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Updated 7/14/2012 FOR IMMEDIATE RELEASE 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… Continue reading →