Navigation Links
OsteoFab™ Patient Specific Cranial Device Receives 510(k) Approval
Date:2/18/2013

South Windsor, CT (PRWEB) February 18, 2013

Oxford Performance Materials (OPM) is pleased to announce it has received FDA 510(k) clearance for the OsteoFab™ Patient Specific Cranial Device (OPSCD). “OsteoFab” is OPM’s brand for Additively Manufactured medical and implant parts produced from PEKK polymer. With OPM’s Additive Manufacturing process (also called “3D Printing”), implants are “grown” layer by layer directly from a digital CAD file without the aid of tooling and with few practical limits on what can be produced. As such, the OsteoFab™ technology is ideal for one-off implants specifically shaped to each patient’s anatomy. One very desirable use of patient specific implants and the indication for the OPSCD is cranial implants to replace bony voids in the skull due to trauma or disease. FDA clearance of this device marks the first approval for an additively manufactured polymer implant.

In addition to the importance of implant fit, implant material is a critical consideration. The OPSCD is manufactured from PEKK, an ultra high performance polymer used in biomedical implants and other highly demanding applications. OPM had traditionally sold PEKK as a raw material or in a semi-finished form, but began developing Additive Manufacturing technologies in 2006. In 2011, OPM established a biomedical compliant manufacturing facility in South Windsor, CT to support its growing Additive Manufacturing business. As an implantable polymer, PEKK is unique in that is biocompatible, mechanically similar to bone, and radiolucent so as not to interfere with X-Ray equipment. Furthermore, OPM has recently completed testing which confirms that the OsteoFab™ implant surface is, in fact, osteoconductive.

“It is our firm belief that the combination of PEKK and Additive Manufacturing (our OsteoFab™ technology) is a highly transformative and disruptive technology platform that will substantially impact all sectors of the orthopedi
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

Related biology technology :

1. University of Colorado Cancer Center Study Shows the Preferred Feeding Method is not the Medically Best in Malnourished Pediatric Cancer Patients
2. Lee Biosolutions Helps Make Cancer Patient's Wish Come True
3. Critical Milestone Achieved in NaF Clincial Trials: 500+ Patients Enrolled
4. ALS Patients’ Own Stem Cells Show Promise as a Future Treatment Option
5. Shire Regenerative Medicine Initiates Phase 3 Study of ABH001 for Patients with Epidermolysis Bullosa
6. University of Colorado Cancer Center Review Shows Long-term Side-effects of New, Targeted Therapies in Pediatric Cancer Patients
7. Deborah Morosini, MD Pathologist and Patient Advocate Signs on as Medical Director and Advisory Board Member of Store-A-Tooth™ Dental Stem Cell Banking
8. Kitware Provides Mobile Visualization Support for the Visible Patient Project
9. adams & weber GmbH and Ekahau Install a Location and Emergency Call System for Dementia Patients and Staff at Josef-Ecker-Stift in Neuwied
10. Inflamax Research Introduces Electronic Patient Data Acquisition Tablet™ (ePDAT)™ for Real-Time PRO Data Collection
11. Caris Life Sciences nimmt Next-Generation Sequencing zur Verbesserung des evidenzbasierten Tumorprofilierungsservices für Krebspatienten auf
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2014)... D.C. (PRWEB) September 18, 2014 On ... Durbin and Sen. Jim Risch for National Lab Day ... projects from across the national laboratory system. Durbin and ... which aims to increase awareness of the reach of ... technologies and discoveries to address some of our nation's ...
(Date:9/18/2014)... 2014 Research and Markets has ... Industry Report 2014" report to their offering. ... is a professional and in-depth study on the current ... The report provides a basic overview of the industry ... human albumin market analysis is provided for the international ...
(Date:9/18/2014)... -- U.S. biotech company Kultevat has strengthened its ... developed by the Donald Danforth Plant Science Center ... applications in production of natural rubber in Taraxicum ... under the direction of Roger Beachy , Ph.D., ... the Danforth Plant Science Center, and is used to ...
(Date:9/18/2014)... Sept. 18, 2014 /PRNewswire/ - Oncothyreon Inc. (NASDAQ: ... announced concurrent but separate underwritten offerings of 10,000,000 shares ... public of $2.00 per share, for expected gross proceeds ... A Convertible Preferred Stock at a price to the ... of $20 million. Each share of Series A Convertible ...
Breaking Biology Technology:Lab Day Highlight Labs' Contribution to U.S. Competitiveness and Innovation 2Lab Day Highlight Labs' Contribution to U.S. Competitiveness and Innovation 3Global Human Albumin Industry Report 2014 2Global Human Albumin Industry Report 2014 3Kultevat obtains license of gene switch technology 2Oncothyreon Prices $40 Million Concurrent Public Offerings of Common Stock and Preferred Stock 2Oncothyreon Prices $40 Million Concurrent Public Offerings of Common Stock and Preferred Stock 3
... - Jason Smith acknowledges he's on a personal mission. The ... of the Peak Ridge Capital Group, wants to bridge the gap ... passion for investing in innovative Midwestern technology companies is one of ... in the morning and it is one of the first things ...
... Wis. - Broadlook Technologies , an Internet ... as the firm's chief operations officer. , ,Meier brings ... sectors, and he will be responsible for helping the ... programs. , ,"I believe in Greg, and he believed ...
... Madison, Wis. - A University of Wisconsin-Madison ... return in the nation, according to BusinessWeek 's latest ... class of 2006 paid $186,800 for their MBAs and started ... even in four and a half years, not counting lost ...
Cached Biology Technology:Investor links East Coast funds to Midwest tech 2Investor links East Coast funds to Midwest tech 3UW-Madison MBA program ranked among best for investment return 2
(Date:9/19/2014)... A new study shows that legume plants regulate ... cytokininssignaling molecules that are transmitted through the plant ... the number of bacteria-holding nodules in the roots. ... the National Institute for Basic Biology, the Graduate ... Center for Sustainable Resource Science in Japan. ...
(Date:9/18/2014)... into the Crimean-Congo hemorrhagic fever virus (CCHFV), a tick-borne ... similar to that caused by Ebolavirus, has identified new ... the potential to lead to novel targets for therapeutic ... reported in a paper published today in the journal ... the Texas Biomedical Research Institute and their colleagues, represents ...
(Date:9/18/2014)... that prompts millions of Americans to undertake jaunts into the ... a little longer within a century, according to new research. ... areas of the United States as summer temperatures linger later ... Global Ecology and Biogeography . For instance, the paper ... tree of New Hampshire could change color one to ...
Breaking Biology News(10 mins):For legume plants, a new route from shoot to root 2Research milestone in CCHF virus could help identify new treatments 2Fall foliage season may be later, but longer on warmer Earth 2Fall foliage season may be later, but longer on warmer Earth 3Fall foliage season may be later, but longer on warmer Earth 4
... interplay of brain chemicals which help us pay attention in ... By changing the way neurons respond to external stimuli we ... strength of a neuronal response, they can also affect the ... Thiele, Professor of Visual Neuroscience explains: "When you communicate with ...
... can detect molecular variants in chemical mixtures greatly ... important, though time-consuming, processes in analytical chemistry. ... post-doctoral researcher David Patterson, Professor of Physics John Doyle ... Laser Science (CFEL) in Hamburg, Germany developed a system ...
... endanger the whole organism, as they may lead to ... Munich now report how byproducts of respiration cause mispairing ... in our cells controls the form and function of ... this are encoded in the linear sequence of the ...
Cached Biology News:Detecting mirror molecules 2Detecting mirror molecules 3DNA damage: The dark side of respiration 2
Comp Dim: chamber diam. depth 20 2.8 mm chamber maximum volume 720 μL...
... vitro diagnostic assays, all EIA/RIA plates are ... binding, high optical clarity and low background ... of the Certified Surface Chemistry Programme, which ... QA release specifications. Linkage: This CLS number ...
... Lipid adsorption and clarification reagent; ... the purification of antibodies, proteins, nucleic ... has negligible cross-reactivity, and improves downstream ... a solid-phase, non-ionic adsorbent supplied as ...
... The lyophilization stabilizer is designed to ... and for long-term storage. There ... ingredients. It is a convenient ... 7.2, and is superior to other ...
Biology Products: