| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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057
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Date of Entry 12/20/2021
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FR Recognition Number
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8-577
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| 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 |
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Scope/AbstractThis 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.
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| Extent of Recognition
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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. |
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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| FDA recognition of ISO 13179-1 First edition 2014-06-01 [Rec# 8-456] will be superseded by recognition of ISO 13179-1 Second Edition 2021-09 [Rec# 8-577].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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §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 |
| §888.3030 |
Plate, Fixation, Bone |
Class 2 |
HRS |
| §888.3070 |
Orthosis, Spinal Pedicle Fixation |
Class 2 |
MNI |
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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
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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