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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 8-577
Standard
ISO 13179-1 Second Edition 2021-09
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
Scope/Abstract
This part of ISO 13179 specifies general requirements for plasma-sprayed unalloyed titanium coatings on metallic surgical implants.

This document applies to atmospheric plasma spraying and vacuum plasma spraying.

This document does not apply to coatings made of other materials than titanium or titanium-6 aluminum-4 vanadium alloy or to coatings realized by another technology than plasma spraying.

NOTE 1 A quality management system can be useful, e.g. as described in ISO 13485. Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.
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FDA recognition of ISO 13179-1 First edition 2014-06-01 [Rec# 8-456] will be superseded by recognition of ISO 13179-1 Second Edition 2021-09 [Rec# 8-577]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-456] until December 18th, 2022. After this transition period, declarations of conformity to [Rec# 8-456] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3030 Plate, Fixation, Bone Class 2 HRS
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3080 Intervertebral Fusion Device With Bone Graft, Lumbar Class 2 MAX
§888.3535 Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Class 2 NJD
§888.3040 Screw, Fixation, Bone Class 2 HWC
§888.3110 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Class 2 HSN
§888.3800 Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Class 2 JWJ
§888.3060 Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate Class 2 OJB
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 LPH
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement, Issued April 1994

Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements, Issued February 2000

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

FDA Technical Contacts
 Limin Sun
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-7056
  limin.sun@fda.hhs.gov
 Nandini Duraiswamy
  FDA/OC/CDRH/OSEL/DAM/
  301-796-5154
  Nandini.Duraiswamy@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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