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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 052 Date of Entry 07/15/2019 
FR Recognition Number 8-493
Standard
ISO  13779-2 Third edition 2018-12
Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
Scope/Abstract
This document specifies requirements for single layer thermally sprayed hydroxyapatite coatings applied to metallic surgical implants.

These requirements are intended to describe properties of the materials and to communicate these between organizations. These requirements are not written with the objective of replacing a company's internal operational and assessment requirements although they could be used as such.


NOTE 1 For thin coatings with a thickness of less than 50 µm, some of the test methods described in this document might be difficult to apply without modification.


NOTE 2 The requirements of the hydroxyapatite layer of dual-layer coatings (consisting of a lower layer of metallic coating and an upper layer of hydroxyapatite coating) can follow this document; however, testing methods referred to in this document cannot be applied to dual layer coatings. If this document is taken in reference for the requirements of the hydroxyapatite layer of dual layer coatings, a rationale on how the single-layer tested coupons are representative of the dual-layer coated implant might be considered necessary.

This document does not cover coatings made from glasses, glass ceramics, alpha- and beta-tricalcium phosphate, biphasic calcium phosphate or other forms of calcium phosphate.


NOTE 3 While the requirements in this document are intended to be used as specifications of a thermally sprayed coating of hydroxyapatite, it might be necessary to establish routine control procedures specifying control tests and their time intervals to make sure the characteristics of the coating stay within specified limits.


NOTE 4 This document was developed with a focus on plasma sprayed coating of hydroxyapatite. It might also be used to characterize other thermally sprayed coatings of hydroxyapatite. However, thermally sprayed coatings that do not have a history of clinical use might present different risks and might need additional characterizations beyond those identified in this document.
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
§888.3045 Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Class 2 MBP
§888.3045 Filler, Bone Void, Calcium Compound Class 2 MQV
§888.3045 Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation Class 2 OIS
§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 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§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
§888.3358 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class 2 OQG
§888.3535 Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Class 2 NJD
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
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

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 Contact
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  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
*These are provided as examples and others may be applicable.
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