| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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8-608
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| Standard | |
ASTM F2214-23
Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
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Scope/Abstract1.1 This test method describes how the crosslink density, molecular weight between crosslinks, and number of repeat units between crosslinks in ultra high molecular weight poly-ethylene (UHMWPE) crosslinked by ionizing radiation or by chemical means can be determined by measuring the swelling ratio of samples immersed in o-xylene. Examples of experi-mental techniques used to make these measurements are discussed herein.
1.2 The test method reported here measures the change in height of a sample specimen while it is immersed in the solvent. Volumetric swell ratios assume that the sample is crosslinked isotropically, and that the change in dimension will be uniform in all directions. This technique avoids uncertainty induced by solvent evaporation or temperature change.
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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| FDA recognition of ASTM F2214-16 [Rec# 8-451] will be superseded by recognition of ASTM F2214-23 [Rec# 8-608]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-451] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-451] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
1. Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices, issued April 2019
2. Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA, issued April 2002
3. Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 2003
4. Guidance for Industry and FDA Staff - Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis, issued October 2000
5. Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components, issued May 1995
6. Guidance for Industry and FDA Staff: Spinal System 510(k)s, issued May 2004
7. Guidance for Industry and/or FDA Reviewer/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, issued January 2000
8. Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs, issued April 2008
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 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. |
