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Recognized Consensus Standards
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Recognition List Number: 029 Publication Date: 08/20/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-241: ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws. (Orthopaedics)

Date of Standard: 2007. 
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:
Metallic bone screws (non-spinal applications)
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Controls
Type of Standard:
 Vertical, National, Test Methods
Extent of Recognition:
Complete Standard

The standard describes methods to assess the torque to failure, insertion torque, axial pullout strength, and self-tapping performance of screws. Parts of this testing may also be applicable to fixator pins and suture anchors. Additional testing is required for screws used in spinal applications.

The specification standard provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws implanted into bone tissue. As the specification standard states, the dimensions and tolerances are applicable only to metallic bone screws described in thie specification itself. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3040 Fastener, Fixation, Nondegradable, Soft Tissue Class 2 MBI
§888.3040 Pin, Fixation, Threaded Class 2 JDW
§888.3040 Pin, Fixation, Threaded, Metallic Class 2 NDM
§888.3040 Screw, Fixation, Bone Class 2 HWC
§888.3040 Screw, Fixation, Bone, Non-Spinal, Metallic Class 2 NDJ
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  Michael Kasser
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1576
  Silver Spring MD 20993
  301/796-6946
  Email: michael.kasser@fda.hhs.gov
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