title: Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration.
abstract: Cervical intervertebral body fusion devices (IBFDs) are utilized to provide stability while fusion occurs in patients with cervical pathology. For a manufacturer to market a new cervical IBFD in the United States, substantial equivalence to a cervical IBFD previously cleared by FDA must be established through the 510(k) regulatory pathway. Mechanical performance data are typically provided as part of the 510(k) process for IBFDs. We reviewed all Traditional 510(k) submissions for cervical IBFDs deemed substantially equivalent and cleared for marketing from 2007 through 2014. To reduce sources of variability in test methods and results, analysis was restricted to cervical IBFD designs without integrated fixation, coatings, or expandable features. Mechanical testing reports were analyzed and 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), and percentile distributions of performance measurements were calculated. Eighty-three (83) submissions met the criteria for inclusion in this analysis. The median device yield strength was 10,117N for static axial compression, 3680N for static compression-shear, and 8.6Nm for static torsion. Median runout load was 2600N for dynamic axial compression, 1400N for dynamic compression-shear, and ±1.5Nm for dynamic torsion. In subsidence testing, median block stiffness (Kp) was 424N/mm. The mechanical performance data presented here will aid in the development of future cervical IBFDs by providing a means for comparison for design verification purposes.
authors.affiliation: 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.
authors.forename: Jonathan H
authors.initials: JH
authors.lastname: Peck
authors.affiliation: University of California at San Francisco, Department of Orthopedic Surgery, San Francisco, CA 94143, USA; 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.
authors.forename: David C
authors.initials: DC
authors.lastname: Sing
authors.affiliation: 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.
authors.forename: Srinidhi
authors.initials: S
authors.lastname: Nagaraja
authors.affiliation: 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.
authors.forename: Deepa G
authors.initials: DG
authors.lastname: Peck
authors.affiliation: University of California at San Francisco, Department of Orthopedic Surgery, San Francisco, CA 94143, USA.
authors.forename: Jeffrey C
authors.initials: JC
authors.lastname: Lotz
authors.affiliation: 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.
authors.forename: Anton E
authors.initials: AE
authors.lastname: Dmitriev
mesh_terms: D002574:Cervical Vertebrae / Q000502:physiology*; D006801:Humans; D008422:Materials Testing; D019736:Prostheses and Implants; D011474:Prosthesis Design; D013123:Spinal Fusion / Q000295:instrumentation* / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
keywords: ASTM F2077; ASTM F2267; Cervical cage; Cervical intervertebral body fusion device; Mechanical testing