| 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
|
11-385
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| Standard | |
ASTM F2345-21
Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
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Scope/Abstract1.1 These test methods cover the evaluation of the cyclic fatigue strength of ceramic modular femoral heads, mounted on a cone as used on the femoral stem of the total hip arthroplasty.
1.2 These test methods were primarily developed for evaluation of ceramic (Specification F603, ISO 6474-1, ISO 6474-2, ISO 13356) head designs on metal cones but may have application to other materials. |
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| Extent of Recognition
|
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 |
| §888.3300 |
Prosthesis, Hip, Constrained, Metal
|
Class 3
|
KXD
|
| §888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
|
Class 2
|
KWZ
|
| §888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
|
Class 2
|
PBI
|
| §888.3320 |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
|
Class 3
|
JDL
|
| §888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
Class 3
|
KWA
|
| §888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal
|
Class 2
|
KMC
|
| §888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
Class 2
|
JDI
|
| §888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
|
Class 2
|
OQH
|
| §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
|
| §888.3360 |
Prosthesis, Upper Femoral
|
Class 2
|
JDD
|
| §888.3360 |
Prosthesis, Hip, Femoral Component, Cemented, Metal
|
Class 2
|
JDG
|
| §888.3360 |
Prosthesis, Hip, Hemi-, Femoral, Metal
|
Class 2
|
KWL
|
| §888.3360 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
|
Class 2
|
LWJ
|
| §888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
|
Class 2
|
KWY
|
| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented |
Class 3
|
LPF
|
| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3
|
MRA
|
| N/A |
Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation |
Class 3
|
OVO
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems, issued January 1995.
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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