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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 8-226
Standard
ASTM  F603-12 (Reapproved 2020)
Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
Scope/Abstract
1.1 This specification covers the material requirements for high-purity, dense aluminum oxide for load-bearing surgical implant applications.

1.2 This specification does not cover finished parts (for example, femoral heads, acetabular inserts, dental implants and the like). It is intended as a qualification of the material as delivered to the parts manufacturer.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3630 Abutment, Implant, Dental, Endosseous Class 2 NHA
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer Class 3 KXB
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented Class 3 OCG
N/A Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented Class 3 LPF
N/A Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 MRA
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for the Preparation of Premarket Notification For Ceramic Ball Hip Systems, January 10, 1995.

Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Guidance for Industry and FDA Staff, May 12, 2004.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Peter Allen
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6402
  peter.allen@fda.hhs.gov
 Limin Sun
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-7056
  limin.sun@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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