Category Archives: FDA Approvals

Polymotion® IDE Study Reaches 30% Enrollment Milestone

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23 Jun 2025

Momentum Builds as Polymotion® Hip Resurfacing IDE Study Reaches 30% Enrolment and Expands to Nine Active Sites in the US.

We are pleased to announce that the Polymotion® Hip Resurfacing (PHR®) IDE study has now reached 30% of its target enrolment. This reflects the strong momentum behind the study and mission to bring this next-generation hip resurfacing technology to patients in the United States.

 

In line with this momentum, we’ve also

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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. Click the Contact Site link at each site to contact your preferred location.

 

1  Florida Medical Clinic Orlando Health

Tampa, Florida, United States  33613

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US Clinical Trials for Polymotion Hip Resurfacing (PHR) System Started

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Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty (PHR)  – Read Full Study Information Here:   https://clinicaltrials.gov/study/NCT06792539?term=polymotion&rank=1

ClinicalTrials.gov ID NCT06792539

Sponsor JointMedica Inc.  Information provided by JointMedica Inc. (Responsible Party)

Last Update Posted 2025-02-26

Study Overview

Brief Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of the Polymotion Hip Resurfacing (PHR) System compared to total hip arthroplasty, for adults who require … Read the rest

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 mechanism of a US run Multi-center FDA study( approval 7/2007, I was the lead investigator). Therefore, there are now 2 … Read the rest

FDA to Stryker: Fix hip implant flaws

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FDA to Stryker: Fix hip implant flawsLink 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 patient complaints and forced some to have follow-up surgeries. Stryker shares fell almost 2 percent.

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FDA to collect adverse event data 2011

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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 Wales data, which last year showed high revision rates for two ASR hip resurfacing systems, led to a UK medical device alert
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FDA Safety Communication: Metal-on-Metal Hip Implants

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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 consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys.

There are two types of metal-on-metal hip implants1:

  • Traditional

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

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A letter about FDA Approvals and Off Label Hip Resurfacing Components by Dr. Gross

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 mechanism of a US run Multi-center FDA … Read the rest

FDA wants surveillance net for orthopedic devices

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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 implant registries for participation in the program. The program is part of the broader Sentinel Initiative FDA launched earlier this year. The broader
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Food and Drug Administration Safety and Innovation Act Signed

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FOR IMMEDIATE RELEASE July 9, 2012Contact: 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
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