Proposed ASTM Standard covers orthopedic spinal devices.December 9, 2011 -
ASTM WK34549, Test Methods for Intervertebral Body Fusion Devices with Integrated Fixation Components, is being developed by Subcommittee F04.25 on Spinal Devices. Proposed standard is being written primarily to address added functionalities of new devices that stabilize spine after discectomy surgery and act as spacers to prevent nerve compression. Added functionalities include screws, blades, or hooks that latch onto or dig into adjacent bone, serving to prevent implant migration or expulsion.
Proposed ASTM Standard Will Focus on New Functionalities of Orthopedic Spinal Devices
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Press release date: December 6, 2011
W. CONSHOHOCKEN, Pa., -New functionalities in a particular group of orthopedic spinal devices will be addressed in a proposed new ASTM standard. ASTM WK34549, Test Methods for Intervertebral Body Fusion Devices with Integrated Fixation Components, is being developed by Subcommittee F04.25 on Spinal Devices, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.
According to Andrew Dooris, Ph.D., principal engineer, DePuy Spine, and the F04 member who is heading the task group for ASTM WK34549, intervertebral fusion devices have been in use for approximately 15 years. These devices stabilize the spine after discectomy surgery, and act as spacers to keep the vertebral bodies separated in order to prevent nerve compression. The devices are usually supplemented by additional fixation, such as pedicle screw hardware.
"In the past few years there has been a proliferation of devices similar to these intervertebral body fusion devices, in that they too are spacers made of similar materials in similar shapes and inserted with similar techniques, but with an added functionality - they have screws, blades or hooks that latch onto or dig into the adjacent bone," says Dooris. "These additional components may serve to prevent implant migration or expulsion or may help prevent separation of the bone from the device when under significant body torque. In some cases, these devices may obviate the need for additional hardware."
Dooris says that ASTM WK34549 is being written primarily to address the added functionalities of these new devices.
"The proposed test method will be useful to manufacturers and the U.S. Food and Drug Administration by providing additional guidance on how to evaluate this new breed of intervertebral body fusion devices and perhaps even guide future designs," says Dooris. Once approved, the proposed standard will be used by medical device manufacturers, the U.S. FDA, international regulatory bodies and contract test laboratories.
All interested parties are encouraged to join in the standards developing activities of F04.
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View this release on the ASTM Web site at www.astmnewsroom.org.
ASTM Committee F04 Next Meeting: May 8-11, 2012, May Committee Week, Phoenix, Ariz.
Technical Contact: Andrew Dooris, Ph.D., DePuy Spine, Raynham, Mass., Phone: 508-828-3433; firstname.lastname@example.org
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