Original Press Release
ASTM Medical and Surgical Devices Committee Approves Total Facet Prostheses Practice
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.
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ASTM Committee F04 Next Meeting: Nov. 16-19, November Committee Week, San Antonio, Texas
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