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:2/21/2017)... /PRNewswire/ - SQI Diagnostics Inc. ("SQI" or the "Company") (TSX-V: SQD; ... three months ended December 31, 2016. SQI ... diagnostics company that develops and commercializes proprietary technologies and products ... ... commercial milestones achieved in fiscal 2016," said Andrew Morris ...
(Date:2/21/2017)... ... February 21, 2017 , ... ... and development (R&D), today announced the establishment of Genedata Limited as a new ... Teburi, a recognized expert in life science informatics. Creating the UK subsidiary reinforces ...
(Date:2/21/2017)... ... February 21, 2017 , ... ... Treximo will pair its $200M operational capacity with its strategic internal leadership ... in areas affecting quality and operational management. With office locations in ...
(Date:2/21/2017)... BOTHELL, Wash. and VANCOUVER, British Columbia ... OGXI ) today announced that apatorsen results from ... American Society of Clinical Oncology (ASCO) 2017 Genitourinary Cancers Symposium, ... Orlando . Clinical data from trials in bladder ... outcomes when administered in combination with standard-of-care treatments. ...
Breaking Biology Technology:
(Date:2/16/2017)... FRANCISCO , Feb. 16, 2017  Genos, ... today announced that it has received Laboratory Accreditation ... CAP Accreditation is presented to laboratories that meet ... who demonstrate scientifically rigorous processes. "Genos ... excellence in laboratory practices. We,re honored to be ...
(Date:2/9/2017)... The biomass boiler market report by Transparency Market Research ... in terms of revenue (US$ Mn) based on the ... boilers has been segmented on the basis of feedstock ... based on feedstock type, has been segmented into woody ... urban residues, and others. On the basis of product ...
(Date:2/8/2017)... Report Highlights The global biosurgery market should ... 2016 at a compound annual growth rate (CAGR) of ... An overview of the global market for biosurgery. - ... and 2016, and projections of compound annual growth rates ... the basis of product type, source, application, and region. ...
Breaking Biology News(10 mins):