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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 11-288
Standard
ASTM F2077-14
Test Methods for Intervertebral Body Fusion Devices
Scope/Abstract
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.

1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.

1.3 The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies.

1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.

1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).

1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.

1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ASTM F2077-14 [Rec# 11-288] will be superseded by recognition of ASTM F2077-17 [Rec# 11-331]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-288] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 11-288] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§888.3080 Intervertebral Fusion Device With Bone Graft, Cervical Class 2 ODP
§888.3080 Intervertebral Fusion Device With Bone Graft, Lumbar Class 2 MAX
§888.3080 Intervertebral Fusion Device With Integrated Fixation, Cervical Class 2 OVE
§888.3080 Intervertebral Fusion Device With Integrated Fixation, Lumbar Class 2 OVD
§888.3060 Spinal Vertebral Body Replacement Device Class 2 MQP
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007

Guidance for Industry and FDA Staff Spinal System 510(k)s, May 3, 2004
FDA Technical Contact
 Jonathan Peck
  FDA/OMPT/CDRH/ODE/DOD/PSDB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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