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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 8-188
Standard
ISO 13779-2 Second edition 2008-10-01
Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite
Scope/Abstract
This part of ISO 13779 specifies requirements for ceramic hydroxyapatite coatings applied to metallic or non-metallic surgical implants.

This part of ISO 13779 does not cover coatings made from glasses, glass ceramics, alpha- and beta-calcium orthophosphate or other forms of calcium phosphate, nor does it cover coatings in which the hydroxyapatite is present in a powder form.

This part of ISO 13779 does not apply to nanoparticle-type materials

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FDA recognition of ISO 13779-2 Second edition 2008-10-01 [Rec# 8-188] will be superseded by recognition of ISO 13779-2 Third edition 2018-12 [Rec# 8-493]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-188] until July 26, 2020. After this transition period, declarations of conformity to [Rec# 8-188] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§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
§888.3535 Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Class 2 NJD
§888.3358 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class 2 OQG
§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
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3045 Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation Class 2 OIS
§888.3045 Filler, Bone Void, Calcium Compound Class 2 MQV
§888.3045 Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Class 2 MBP
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

510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants, Issued March 1995 (revised 2/20/97)

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

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device, Issued June 2003
FDA Technical Contact
 John Goode
  FDA/OMPT/CDRH/ODE/DOD/JFDB2/
  301-796-6407
  john.goode@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Materials
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