Navigation Links
FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems
Date:10/5/2009

.

Traditional, rigid stabilization systems have been on the market for decades, and provide stability via screws inserted into segments of the spine. The screws act as anchors that are then connected by uniform metallic rods, which immobilize the spinal segments and facilitate fusion. These systems are not intended to allow motion.

When intended as stabilizers during bone fusion, this type of device is class II and is subject to FDA's premarket notification requirement (also known as 510(k)). Devices subject to this requirement are cleared for marketing in the United States if FDA finds them to be substantially equivalent to legally marketed predicate devices.

The FDA cleared the first dynamic stabilization system component in 1997. The FDA has cleared numerous dynamic stabilization systems or components since then. FDA has only ordered postmarket surveillance studies for the class II dynamic stabilization systems and components, which are intended for bone fusion.

The FDA has required the manufacturers of 16 dynamic stabilization systems or components on the market for spinal fusion to conduct postmarket surveillance studies, which must address the following:

  • the fusion rate for dynamic stabilization systems compared to traditional stabilization systems;
  • the incidence rate, severity, and time course of adverse events for dynamic stabilization systems compared to traditional stabilization systems;
  • the type, incidence rate, and time course of subsequent surgical procedures for dynamic stabilization systems compared to traditional stabilization systems; and
  • the cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient's demographic and clinical data and the device failure.

In revie
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Quest Diagnostics Introduces ClariSure(TM) Test for Identifying Chromosome Abnormalities Associated With 85 Developmental Disorders in Children
2. S*BIO to Develop New JAK-2 Inhibitor for Treatment of Myeloproliferative Disorders and Hematological Malignancies
3. Hyperion Therapeutics Announces Enrollment of First Patient in Phase 1/2 Clinical Trial of GT4P in Patients With Urea Cycle Disorders
4. Mayo Clinic Physicians Report Findings from Research on Sleep Disorders
5. Bristol-Myers Squibb, New Jersey Childrens Hospital Launch Center for Immune System Disorders & Infectious Diseases Including HIV/AIDS
6. Study Finds Fever may Lead to Improved Behavior in Children with Autism Spectrum Disorders
7. Lexicon Initiates Phase 2a Trial of LX6171 Drug Candidate for Cognitive Disorders
8. MJFF and Merck Serono (EMD Serono in North America) Join Forces on $2-Million Initiative to Drive Treatments for PD-Related Cognitive Dysfunction and Mood Disorders
9. Rigel Announces Initiation of Phase 1 Clinical Trial of R348 for Rheumatoid Arthritis, Psoriasis and Other Immune Disorders
10. Intra-Cellular Therapies Presents Data on Its Schizophrenia and Cognition in Schizophrenia Programs at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders
11. Cytopia Nominates JAK2 Clinical Candidate for Myeloproliferative Disorders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/15/2014)... , December 15, 2014 ... Am 19. und 20. Februar sind alle ... SAFE MEDICINE ECOSYSTEM PARTNER PROGRAMM ™ 2015 ... besuchen. Diese Tagung soll dazu ... Möglichkeit geben, die neue profitablen Unternehmensdienstleistungen, die ...
(Date:12/15/2014)... , Dec. 12, 2014 Research and Markets ... the "Inferior Vena Cava (IVC) Filters - Global ... offering. http://photos.prnewswire.com/prnh/20130307/600769 ... projected to reach US$435 million by 2016. The ... (2015) of the global value while Europe ...
(Date:12/15/2014)... YORK and HERZLIYA PITUACH, Israel ... "Company") (NASDAQ: IMNP ) announced today that its ... the Board succeeding Dr. Daniel Teper who continues ... a member of Immune,s Board of Directors since 2013. ... "I am delighted to represent the interest of shareholders and ...
Breaking Medicine Technology:Symposium über Aegates Ecosystem-Partner-Programm für sichere Medikamente vom 19. - 20. Februar 2015 in Amsterdam 2Inferior Vena Cava (IVC) Filters - Global Trends, Estimates and Forecasts, 2012-2018 2Inferior Vena Cava (IVC) Filters - Global Trends, Estimates and Forecasts, 2012-2018 3Inferior Vena Cava (IVC) Filters - Global Trends, Estimates and Forecasts, 2012-2018 4Immune Pharmaceuticals Elects Daniel Kazado as New Chairman of the Board. 2Immune Pharmaceuticals Elects Daniel Kazado as New Chairman of the Board. 3Immune Pharmaceuticals Elects Daniel Kazado as New Chairman of the Board. 4
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... Orchid Cellmark Inc. (Nasdaq: ORCH ), a leading ... financial results for the fourth quarter and full year of ... compared to $15.0 million for the fourth quarter of 2007. ... $60.3 million for the full year of 2007. The decline ...
... STXS ) today announced that it has extended its ... SVB Financial Group (Nasdaq: SIVB ). Under ... Company can borrow up to $25 million. "This extension ... position and other financing sources, provides us with the financial ...
... Meal Recipes, Educational Games and More Now Available SAN FRANCISCO, ... initiative to provide the public with information about how the ... brains healthy. In honor of Brain Awareness Week, which begins ... online that help people understand how the brain operates and ...
... HORSHAM, Pa. and TEL AVIV, Israel, March 16 ... of a strategic partnership agreement to provide a total, ... hemodynamic cardiovascular patient data to their customers. LUMEDX is ... more than 500 hospitals worldwide. With a presence ...
... Deerfield ManagementBEDFORD, Mass, March 16 Insulet Corporation ... tubing-free insulin pump technology with its OmniPod(R) Insulin ... into an agreement with leading healthcare investor, Deerfield ... $60 million in financing through a flexible credit ...
... both Raima Database Manager (RDM) products in April. ... and RDM Server will be released as version ... availability by providing replication between RDM Embedded databases ... of embedded systems with an easy method to ...
Cached Medicine News:Health News:Orchid Cellmark Reports Fourth Quarter and Full Year 2008 Financial Results 2Health News:Orchid Cellmark Reports Fourth Quarter and Full Year 2008 Financial Results 3Health News:Orchid Cellmark Reports Fourth Quarter and Full Year 2008 Financial Results 4Health News:Orchid Cellmark Reports Fourth Quarter and Full Year 2008 Financial Results 5Health News:Orchid Cellmark Reports Fourth Quarter and Full Year 2008 Financial Results 6Health News:Orchid Cellmark Reports Fourth Quarter and Full Year 2008 Financial Results 7Health News:Orchid Cellmark Reports Fourth Quarter and Full Year 2008 Financial Results 8Health News:Stereotaxis Extends Its Credit Facility With Silicon Valley Bank 2Health News:Stereotaxis Extends Its Credit Facility With Silicon Valley Bank 3Health News:Posit Science Provides Free Brain Health Tips and Tools in Celebration of Brain Awareness Week 2Health News:LUMEDX and Mennen Medical(R) Announce Agreement for a Strategic Cooperation 2Health News:LUMEDX and Mennen Medical(R) Announce Agreement for a Strategic Cooperation 3Health News:Insulet Receives $60 Million Funding Commitment 2Health News:Insulet Receives $60 Million Funding Commitment 3Health News:Insulet Receives $60 Million Funding Commitment 4Health News:Insulet Receives $60 Million Funding Commitment 5Health News:Birdstep Technology Announces The Dual Upcoming Release Of Its Raima Database Manager Products 2Health News:Birdstep Technology Announces The Dual Upcoming Release Of Its Raima Database Manager Products 3
... Finntips have been designed to optimize the ... of our tip products is widely recognized ... range has been extended over the years ... standard and special tips including filter tips, ...
The BioCheck LH ELISA is intended for the quantitative determination of luteinizing hormone (LH) in human serum. This assay is useful in the diagnosis and treatment of gonadal dysfunction....
... (LH) is a glycoprotein secreted by the ... and TSH, the intact LH molecule is ... These glycoproteins all have homologous alpha-subunits, however ... LH and FSH production and secretion are ...
The NPT7 blood gas analyzer measures pH/blood gases and oximetry on 90 L sample volume with a two-step sampling procedure. Clinical tests compare NPT7 accuracy to that of benchtop analyzers. 30 sampl...
Medicine Products: