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ASTM Committee approves total facet prostheses practice.

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September 15, 2010 - Developed by Subcommittee F04.25 on Spinal Devices, ASTM F2790, Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses could be applied to all motion-preserving devices for posterior of spine, not just total facet prostheses. Additionally, standard may serve to provide alternate method of evaluating fusion devices under more physiologic conditions and allowing comparison to motion-preserving devices.

ASTM Medical and Surgical Devices Committee Approves Total Facet Prostheses Practice


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ASTM International
100 Barr Harbor Dr., Box C700
West Conshohocken, PA, 19428-2959
USA



Press release date: September 13, 2010

W. CONSHOHOCKEN, Pa., -Subcommittee F04.25 on Spinal Devices has been proactive in developing and advancing standards that can be used by the medical community for testing prosthetic devices in their early stages of development. The latest F04.25 standard to provide this opportunity is ASTM F2790, Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses.

Subcommittee F04.25 is under the jurisdiction of ASTM International Committee F04 on Medical and Surgical Materials and Devices.

According to David Rosler, senior neural interfaces program manager, Providence Veterans Affairs Medical Center, ASTM F2790 could be applied to all motion-preserving devices for the posterior of the spine, not just total facet prostheses.

"Some devices, such as interspinous spacers and dynamic stabilizer devices, may require a modification in the fixtures or setup, however this is allowed by F2790," says Rosler. "Additionally, the standard may serve to provide an alternate method of evaluating fusion devices under more physiologic conditions and allowing comparison to motion-preserving devices."

Because of the current limited commercial availability of posterior based motion-preserving devices, Rosler feels that the most practical applications of ASTM F2790 at this point would be for evaluating iterative design or multiple product lines by a manufacturer. Rosler also notes that F04.25 has grown considerably in both size and participation during the last decade. "There is a large interest in creating new standards to keep up with the growth of this segment of the orthopaedic industry," says Rosler.

To purchase ASTM standards, visit www.astm.org and search by the standard designation number, or contact ASTM Customer Relations (phone: 610-832-9585; service@astm.org). ASTM International welcomes and encourages participation in the development of its standards. For more information on becoming an ASTM member, visit www.astm.org/JOIN.

ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions.

View this release on the ASTM Web site at www.astmnewsroom.org.

ASTM Committee F04 Next Meeting: Nov. 16-19, November Committee Week, San Antonio, Texas

Technical Contact: David Rosler, Providence Veterans Affairs Medical Center, Providence, R.I., Phone: 401-402-0367; dmrosler@gmail.com

ASTM Staff Contact: Daniel Schultz, Phone: 610-832-9716; dschultz@astm.org

ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org

www.astm.org
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