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J Biomech. 2018 Sep 10;78:87-93. doi: 10.1016/j.jbiomech.2018.07.022. Epub 2018 Jul 17.

Mechanical performance of lumbar intervertebral body fusion devices: An analysis of data submitted to the Food and Drug Administration.

Author information

1
U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Orthopedic Devices, Silver Spring, MD 20993, USA. Electronic address: jonathan.peck@fda.hhs.gov.
2
U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Orthopedic Devices, Silver Spring, MD 20993, USA.
3
U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Division of Postmarket Surveillance, Silver Spring, MD 20993, USA.
4
U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics, Silver Spring, MD 20993, USA.

Abstract

Lumbar intervertebral body fusion devices (L-IBFDs) are intended to provide stability to promote fusion in patients with a variety of lumbar pathologies. Different L-IBFD designs have been developed to accommodate various surgical approaches for lumbar interbody fusion procedures including anterior, lateral, posterior, and transforaminal lumbar interbody fusions (ALIF, LLIF, PLIF, and TLIF, respectively). Due to design differences, there is a potential for mechanical performance differences between ALIF, LLIF, PLIF, and TLIF devices. To evaluate this, mechanical performance and device dimension data were collected from 124 Traditional 510(k) submissions to the FDA for L-IBFDs cleared for marketing from 2007 through 2016. From these submissions, mechanical test results were aggregated for seven commonly performed tests: static and dynamic axial compression, compression-shear, and torsion testing per ASTM F2077, and subsidence testing per ASTM F2267. The Kruskal-Wallis test and Wilcoxon signed-rank test were used to determine if device type (ALIF, LLIF, PLIF, TLIF) had a significant effect on mechanical performance parameters (static testing: stiffness and yield strength; dynamic testing: runout load; subsidence testing: stiffness [Kp]). Generally, ALIFs and LLIFs were found to be stiffer, stronger, and had higher subsidence resistance than PLIF and TLIF designs. These results are likely due to the larger footprints of the ALIF and LLIF devices. The relative mechanical performance and subsidence resistance can be considered when determining the appropriate surgical approach and implant for a given patient. Overall, the mechanical performance data presented here can be utilized for future L-IBFD development and design verification.

KEYWORDS:

ALIF; ASTM F2077; ASTM F2267; LLIF; Lumbar cage; Lumbar intervertebral body fusion device; Mechanical testing; PLIF; TLIF

PMID:
30060922
DOI:
10.1016/j.jbiomech.2018.07.022
[Indexed for MEDLINE]

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