| 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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8-579
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| Standard | |
ISO 13779-3 Second Edition 2018-12
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |
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Scope/AbstractThis document specifies methods of test for the chemical analysis, assessment of crystallinity ratio and phase composition of hydroxyapatite-based materials such as powders, coating or bulk products.
NOTE These tests are intended to describe properties of the material and to communicate these between organizations. These tests are not written with the objective of replacing a company's internal operational and assessment tests although they could be used as such.
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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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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)
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Class 2
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MBP
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| §888.3045 |
Filler, Bone Void, Calcium Compound
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Class 2
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MQV
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| §888.3045 |
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
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Class 2
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OIS
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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Class 2
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LZO
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
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Class 2
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MAY
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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Class 2
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MEH
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| §888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
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Class 2
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OQI
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| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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Class 2
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LPH
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| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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Class 2
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MBL
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| §888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
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Class 2
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OQG
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| §888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
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Class 2
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NJD
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| §888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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Class 2
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MBH
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| §888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
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Class 2
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MBF
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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
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. |
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| FDA Technical Contact
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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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