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ASTM Selected Technical Papers

Spinal Implants: Are We Evaluating Them Appropriately?

By
MN Melkerson, M.S.
MN Melkerson, M.S.
1
Symposium chairman and co-editor
;
Food Drug Administration Center for Devices and Radiological Health Office of Device Evaluation
?
9200 Corporate Boulevard Rockville, MD 20850
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JS Kirkpatrick, M.D.
JS Kirkpatrick, M.D.
2
Symposium co-chairman and co-editor
;
University of Alabama, Birmingham and Birmingham Veterans Administration Medical Center
?
940 Faculty Office Tower 510 20th Street South Birmingham, Alabama 35294
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S Griffith, Ph.D.
S Griffith, Ph.D.
3
Symposium co-chairman and co-editor
;
Centerpulse Spine-Tech Division
?
7375 Bush Lake Road Minneapolis, MN 55439
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ISBN-10:
0-8031-3463-0
ISBN:
978-0-8031-3463-8
No. of Pages:
246
Publisher:
ASTM International
Publication date:
2003
Description

Meet the challenges and demands facing professionals in the dynamic field of spinal implants. Sections cover:

Spinal Constructs presents developments and results associated with the application of ASTM F1717 test methods. Papers describe the clinical results from spinal constructs having marketing clearance or approval using these test methods; address device failure modes; and examine corrosion seen with explanted devices. Other papers evaluate impact on results due to gauge length used in tests; mobility or constraint of the test blocks; and use of transverse rod connections.

Spinal Device Components, Subassemblies, and Interconnections using ASTM F1798, this section discusses test methods for new components or modifications to existing components of a construct. Papers describe the impact from application of different transverse connector designs on clinical outcomes; and evaluate impact on bench testing results due to protection of the longitudinal member, anchoring materials, gauge length, mobility or constraint of the test blocks.

Interbody Spacers and Intervertebral Body Fusion Devices provides the latest developments and results associated with the application of ASTM F2077 test methods for intervertebral body fusion devices. Papers cover the clinical results from lumbar interbody fusion devices; the causes of some of these devices that extruded; strength testing methodologies; and the usefulness of pull-out or push-out testing for spinal cages.

Functional Spinal Devices and/or Artificial Discs examines comparative cadaveric testing, durability testing, and alternative test methods for spinal constructs intended for posterior stabilization without fusion.

Suggested Test Methods, Models, Fixtures, or Needed Improvements addresses today's limitations and tomorrow's concerns in spinal implants standards. Some papers describe the results from alternative models for fusion, non-fusion, or functional spinal implants; and others examine the impact on testing due to preload, block design, and material properties.

Audience: This new publication is a valuable resource for designing engineers, surgeons, researchers, and regulatory entities who test and evaluate the appropriateness of a devices' design and materials.

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