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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 022 Publication Date: 09/08/2009 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-211: ASTM F1798-97(Reapproved 2008), Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. (Orthopaedics)

Date of Standard: 2008. 
Address of Standards Organization:
  ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Spinal implant systems where clearance or approval for a change to the previously cleared or approved sub-assembly (interconnection mechanism) is being sought. These sub-assemblies (interconnection mechanisms) are part of a spinal implant system intended for posterior (interlaminal), anterior/anteriolateral (intervertebral body), and posterior (pedicle) fixation.
Processes Affected:
510(K), IDE, PMA, PDP, Design Controls
Type of Standard:
 Test Methods, National, Vertical
Extent of Recognition:
Complete Standard.

Test methods provide examples of acceptable types of static and fatigue test methods for the characterization of spinal implant sub-assemblies (interconnection mechanisms) intended for posterior (interlaminal), anterior/anteriolateral (intervertebral body), and posterior (pedicle) fixation. Additional information should be provided to document that the design of the product will provide adequate mechanical properties for the particular application. In applications subjected to wear or articulation, additional data should be provided to document resistance to wear and abrasion.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
Unclassified Spinal Pedicle Screw, Fixation, Appliance System Class 3 MCV
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3060 Appliance, Fixation, Spinal Intervertebral Body Class 2 KWQ
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
 
Relevant Guidance:
Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000
FDA Technical Contact:
  Jonathan Peck
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1418
  Silver Spring MD 20993
  301/796-5650
  Email: jonathan.peck@fda.hhs.gov
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