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 orthopedic industry,” said Scott DeFelice, President and CEO of OPM. “We have sought our first approval within cranial implants because the need was most compelling; however, this is just the beginning. We will now move systematically throughout the body in an effort to deliver improved outcomes at lower overall cost to the patient and healthcare provider.” It is OPM’s strategy to undertake all manufacturing and regulatory activities to support patient specific implant product commercialization. The company is seeking well-qualified partners to bring these technologies to market. In addition to its own devices, the company offers bespoke part production for its customers.

About OPM
OPM operates at the intersection of high performance polymers, Additive Manufacturing technologies, and the creation of structures for the biomedical and aerospace sectors. The firm currently has four operating divisions: Biomedical Devices and Parts, Biomedical Raw Materials, Industrial Parts, and Metrology Sciences. OPM was selected to participate in the National Additive Manufacturing Innovation Institute (NAMII) in 2012. OPM is certified ISO 13485 and ISO 9001.

For more information, please visit http://www.oxfordpm.com

Read the full story at http://www.prweb.com/releases/2013/02OPM1st510kapproval/prweb10429061.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

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:4/19/2017)... ... ... The Vibrating Orifice Aerosol Generator (VOAG) was developed in ... known diameters for research applications such as for calibrating droplet measuring instruments, for ... , The VOAG requires forcing liquid out of an orifice about half ...
(Date:4/19/2017)... ... 18, 2017 , ... Alisa Wright, founder and CEO of Singota Solutions ... of Pharmacy in Lafayette, Indiana. , The Distinguished Alumni Award was established in ... and other scientific endeavors. , Wright began her career in the pharmaceutical industry ...
(Date:4/19/2017)... ... April 19, 2017 , ... Nobilis Therapeutics Announces Completion of Landmark ... Clinical Data in its Upcoming Post Traumatic Stress Disorder Trial , Nobilis Therapeutics, ... trial assessing efficacy of its NBTX-001, a xenon-based therapeutic in the treatment of Panic ...
(Date:4/19/2017)... New York, NY (PRWEB) , ... April 19, ... ... working to combat Clostridium difficile (C. diff) infections through education and advocacy. ... lost her life to a C. diff infection, the foundation has become the ...
Breaking Biology Technology:
(Date:4/11/2017)... Fla. , April 11, 2017 ... and secure authentication solutions, today announced that it ... Intelligence Advanced Research Projects Activity (IARPA) to develop ... Thor program. "Innovation has been a ... IARPA,s Thor program will allow us to innovate ...
(Date:4/5/2017)... Allen Institute for Cell Science today announces the launch ... dynamic digital window into the human cell. The website ... deep learning to create predictive models of cell organization, ... suite of powerful tools. The Allen Cell Explorer will ... resources created and shared by the Allen Institute for ...
(Date:3/30/2017)... -- On April 6-7, 2017, Sequencing.com will host the world,s ... at Microsoft,s headquarters in Redmond, Washington ... health and wellness apps that provide a unique, personalized ... is the first hackathon for personal genomics and the ... the genomics, tech and health industries are sending teams ...
Breaking Biology News(10 mins):