Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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8-404
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Standard | |
ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates |
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Scope/Abstract1.1 This test method covers the determination of fatigue crack growth rates from near-threshold to Kmax controlled instability. Results are expressed in terms of the crack-tip stress-intensity factor range (ΔK), defined by the theory of linear elasticity.
1.2 Several different test procedures are provided, the optimum test procedure being primarily dependent on the magnitude of the fatigue crack growth rate to be measured.
1.3 Materials that can be tested by this test method are not limited by thickness or by strength so long as specimens are of sufficient thickness to preclude buckling and of sufficient planar to remain predominantly elastic during testing.
1.4 A range of specimen s with proportional planar dimensions is provided, but is variable to be adjusted for yield strength and applied force. Specimen thickness may be varied independent of planar .
1.5 The details of the various specimens and test configurations are shown in Annex A1 - Annex A3. Specimen configurations other than those contained in this method may be used provided that well-established stress-intensity factor calibrations are available and that specimens are of sufficient planar to remain predominantly elastic during testing.
1.6 Residual stress/crack closure may significantly influence the fatigue crack growth rate data, particularly at low stress-intensity factors and low stress ratios, although such variables are not incorporated into the computation of ΔK. |
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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 |
§888.3160 |
Prosthesis, Elbow, Semi-Constrained, Cemented
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Class 2
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JDB
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§888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
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Class 2
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KWZ
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§888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
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Class 2
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PBI
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§888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal
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Class 2
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KMC
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§888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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Class 2
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JDI
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§888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
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Class 2
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OQH
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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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§888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
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Class 2
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KWY
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§888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
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Class 3
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OCG
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§888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
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Class 2
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KMB
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§888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
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Class 2
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KTX
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§888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
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Class 2
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KYK
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§888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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Class 2
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KRO
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§888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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Class 2
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HSX
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§888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
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Class 2
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HRY
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§888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
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Class 2
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LGE
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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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§888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
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Class 2
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KRR
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§888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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Class 2
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JWH
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§888.3560 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
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Class 2
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MBV
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§888.3560 |
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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Class 2
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NPJ
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§888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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Class 2
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OIY
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§888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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Class 2
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KWT
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§888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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Class 2
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KWS
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§888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
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Class 2
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PAO
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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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§888.3800 |
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
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Class 2
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JWI
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§888.3800 |
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
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Class 2
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JWJ
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§888.3800 |
Prosthesis, Wrist, Semi-Constrained
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Class 2
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KWM
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§888.3810 |
Prosthesis, Wrist, Hemi-, Ulnar
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Class 2
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KXE
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Relevant FDA Guidance and/or Supportive Publications*
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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