|By Business Wire||
|February 4, 2013 10:10 AM EST||
K7 LLC’s K7C™ Cervical Spacer, a spinal implant device using Evonik’s VESTAKEEP® PEEK (polyetheretherketone), has received the U.S. Food and Drug Administration’s (FDA) 510(k) approval for use as an Intervertebral Body Fusion (IBF) device.
This marks the first time a VESTAKEEP® PEEK-based spinal fusion medical device has gained 510(k) approval from the FDA. The K7C™ Cervical Spacer is one of several PEEK-based spinal implant devices being developed by K7 LLC.
Michael Smith, founder and CEO of K7 LLC attributed VESTAKEEP® PEEK’s durability as a key component in gaining FDA 510(k) clearance. “We could not be more pleased with the test results and material durability of VESTAKEEP® PEEK,” said Smith. “The inherent strength and added ductility have created new possibilities for our PEEK implant designs.”
Evonik’s customers can reference the VESTAKEEP® PEEK product line Masterfiles (MAF), documents containing comprehensive test data on the product’s mechanical and biocompatible properties that meet FDA regulatory requirements, to help guide future registration processes for implant medical devices.
“Creating innovative solutions for our customers is a core component of Evonik,” said Sanjeev Taneja, vice president of Evonik’s High Temperature Polymers Business. “The FDA approval is a testament to the product quality of VESTAKEEP® PEEK and the strength of its MAF. It is also an example of the long-term commitment Evonik has in the medical device and orthopedic industries. This approval validates Evonik as a true player in the implant PEEK market.”
VESTAKEEP® PEEK is known for its superior biocompatibility and biostability. Its excellent sterilization resistance and good combination of stiffness and ductility make it suitable for medical implant applications that must meet extremely high mechanical, thermal, and chemical requirements.
“Significant investments and thorough material testing have been completed on the VESTAKEEP® PEEK product line to ensure Masterfile strength and preparedness,” said Kenneth Ross, Evonik’s VESTAKEEP® medical business development manager in North & South America. “We know VESTAKEEP® PEEK will serve as an outstanding medical material driving innovation in new product ideas and metal replacement developments.”
The VESTAKEEP® PEEK iGrade material also has regulatory clearance for spinal implants in Europe and Asia. With this 510(K) approval, customers will now have easier access to regulatory approvals in the United States market.
Evonik’s VESTAKEEP® PEEK products will be exhibited at the Medical Design and Manufacturing (MD&M) West show in Anaheim, Calif., on February 12-14, and the American Academy of Orthopedic Surgeons (AAOS) show in Chicago, Ill., on March 20-22.
For more information about VESTAKEEP® PEEK product lines, please visit: www.evonik.com/vestakeep
For additional information about Evonik in North America, please visit website: www.evonik.com/north-america
Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Profitable growth and a sustained increase in the value of the company form the heart of Evonik’s corporate strategy. Evonik benefits specifically from its innovative prowess and integrated technology platforms.
Evonik is active in over 100 countries around the world. In fiscal 2011 more than 33,000 employees generated sales of around €14.5 billion and an operating profit (adjusted EBITDA) of about €2.8 billion.
In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release.
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
Aug. 4, 2015 06:45 PM EDT Reads: 225
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. In his session at 15th Cloud Expo, Michael Meiner, an Engineering Director at Oracle, Corporation, analyzed a range of cloud offerings (IaaS, PaaS, SaaS) and discussed the benefits/challenges of migrating to each offe...
Aug. 4, 2015 06:45 PM EDT Reads: 209
SYS-CON Events announced today that the "Second Containers & Microservices Expo" will take place November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
Aug. 4, 2015 05:30 PM EDT
As organizations shift towards IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection and E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his session at 17th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Partnerships at Com...
Aug. 4, 2015 05:00 PM EDT Reads: 107
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
Aug. 4, 2015 03:00 PM EDT Reads: 573
Scrum Alliance has announced the release of its 2015 State of Scrum Report. Almost 5,000 individuals and companies worldwide participated in this year's survey. Most organizations in the market today are still leading and managing under an Industrial Age model. Not only is the speed of change growing exponentially, Agile and Scrum frameworks are showing companies how to draw on the full talents and capabilities of those doing the work in order to continue innovating for success.
Aug. 4, 2015 02:45 PM EDT
SYS-CON Events announced today that MobiDev, a software development company, will exhibit at the 17th International Cloud Expo®, which will take place November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software development company with representative offices in Atlanta (US), Sheffield (UK) and Würzburg (Germany); and development centers in Ukraine. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobi...
Aug. 4, 2015 02:00 PM EDT Reads: 386
Between the compelling mockups and specs produced by your analysts and designers, and the resulting application built by your developers, there is a gulf where projects fail, costs spiral out of control, and applications fall short of requirements. In his session at @DevOpsSummit, Charles Kendrick, CTO and Chief Architect at Isomorphic Software, presented a new approach where business and development users collaborate – each using tools appropriate to their goals and expertise – to build mocku...
Aug. 4, 2015 01:30 PM EDT
Container technology is sending shock waves through the world of cloud computing. Heralded as the 'next big thing,' containers provide software owners a consistent way to package their software and dependencies while infrastructure operators benefit from a standard way to deploy and run them. Containers present new challenges for tracking usage due to their dynamic nature. They can also be deployed to bare metal, virtual machines and various cloud platforms. How do software owners track the usag...
Aug. 4, 2015 01:00 PM EDT Reads: 291
SYS-CON Events announced today that VividCortex, the monitoring solution for the modern data system, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. The database is the heart of most applications, but it’s also the part that’s hardest to scale, monitor, and optimize even as it’s growing 50% year over year. VividCortex is the first unified suite of database monitoring tools specifically desi...
Aug. 4, 2015 12:00 PM EDT Reads: 113
Graylog, Inc., has added the capability to collect, centralize and analyze application container logs from within Docker. The Graylog logging driver for Docker addresses the challenges of extracting intelligence from within Docker containers, where most workloads are dynamic and log data is not persisted or stored. Using Graylog, DevOps and IT Ops teams can pinpoint the root cause of problems to deliver new applications faster and minimize downtime.
Aug. 4, 2015 11:45 AM EDT
As Marc Andreessen says software is eating the world. Everything is rapidly moving toward being software-defined – from our phones and cars through our washing machines to the datacenter. However, there are larger challenges when implementing software defined on a larger scale - when building software defined infrastructure. In his session at 16th Cloud Expo, Boyan Ivanov, CEO of StorPool, provided some practical insights on what, how and why when implementing "software-defined" in the datacent...
Aug. 4, 2015 11:30 AM EDT Reads: 115
Learn how you can use the CoSN SEND II Decision Tree for Education Technology to make sure that your K–12 technology initiatives create a more engaging learning experience that empowers students, teachers, and administrators alike.
Aug. 4, 2015 09:30 AM EDT Reads: 112
Mobile, social, Big Data, and cloud have fundamentally changed the way we live. “Anytime, anywhere” access to data and information is no longer a luxury; it’s a requirement, in both our personal and professional lives. For IT organizations, this means pressure has never been greater to deliver meaningful services to the business and customers.
Aug. 4, 2015 08:45 AM EDT Reads: 259
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
Aug. 4, 2015 07:00 AM EDT Reads: 226