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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 8-63: ISO 5832-11:1994, implants for surgery -- metallic materials -- part 11: wrought titanium 6-aluminium 7-niobium alloy. (Materials)

Date of Standard: 1994. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Implantable Medical Devices
Processes Affected:
510(K), PMA, IDE, PDP, HDE, Design Controls
Type of Standard:
 International, Horizontal
Extent of Recognition:
This standard includes requirements for chemical composition, metallurgical characteristics, and mechanical properties in various conditions. Although this material has a long history of successful use for implants, the standard has no specific requirements regarding biologic response. Refer to the appropriate biocompatibility standards for specific biocompatibility requirements. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. Depending on the device application, additional material property data (such as fatigue life, wear and abrasion resistance, pitting or crevice corrosion resistance, and magnetic susceptibility) may be required beyond what is addressed by this standard.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
§872.3645 Implant, Subperiosteal Class 2 ELE
§872.3890 Splint, Endodontic Stabilizing Class 2 ELS
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
§872.3950 Glenoid Fossa Prosthesis Class 3 MPI
§872.3960 Mandibular Condyle Prosthesis Class 3 MPL
§872.4600 Lock, Wire, And Ligature, Intraoral Class 2 DYX
§872.4760 External Mandibular Fixator And/Or Distractor Class 2 MQN
§872.4760 Implant, Transmandibular Class 2 MDL
§872.4760 Plate, Bone Class 2 JEY
§872.4880 Screw, Fixation, Intraosseous Class 2 DZL
No product code information listed for §872.4XXX, Metallic components
No product code information listed for §888.3XXX, Metallic components of all implantables
FDA Technical Contacts:
 John Goode (Orthopaedics)
  FDA/CDRH/ODE/DGRND
  9200 CORPORATE BLVD, HFZ-410
  ROCKVILLE MD 20850
  240/276-3676
  email: JOHN.GOODE@FDA.HHS.GOV
 Michael J. Ryan (Dental)
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1615
  Silver Spring MD 20993
  301/796-6283
  email: michael.ryan@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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