Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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11-366
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Standard | |
ASTM F2381-19 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
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Scope/Abstract1.1 This test method describes the measurement of the number of trans-vinylene groups in ultra-high molecular weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy.
1.2 This test method is based on Guide F2102.
1.3 The applicability of the infrared method has been demonstrated in other literature reports. This particular method, using the intensity (area) of the C-H absorption centered at 1370 cm-1 to normalize for the sample's thickness, will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691. |
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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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