| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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11-419
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| Standard | |
ASTM F3690-24
Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance |
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Scope/Abstract1.1 This test method provides mechanical performance considerations and standard test methods for measuring basic properties of suture anchors that are implanted into bone. The suture anchors that may be evaluated by this test standard can have varying designs such as "all-suture" anchors (in which the device is made completely of monofilament or multifilament braided wire, tape, or any kind of flexible yarn), or multi-component anchors, such as those which have an anchor body intended for implantation in the bone and separate suture component (for example, threaded anchor, impact anchor, expandable anchors).
1.2 This standard does not address testing methods for absorbable or degradable devices (including anchors and/or sutures). This standard does not address testing methods for device removal or evaluation of device removal risks. The insertion verification testing presented in this standard does not address end user validation testing or usability testing/human factors testing which may need to replicate the operating environment (for example, visualization, knot tying under exposure to biological fluids). Multiple test methods are included in this standard for basic characterization. However, the test types in this standard may not address all end user/customer needs that are important for development of your suture anchor (for example, abrasion testing to evaluate the performance of the anchor/suture interface, characterization of insertion torque or force relative to human factors). The user is not necessarily obligated to use only the tests identified in this standard, nor are they obligated to test their device using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the test methods described herein. This test method does not address the evaluation of other soft tissue fixation devices including but not limited to interference screws or cortical buttons. |
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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 |
| §888.3040 |
Fastener, Fixation, Nondegradable, Soft Tissue
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Class 2
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MBI
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Relevant FDA Guidance and/or Supportive Publications*
Bone Anchors - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff, issued March 2020.
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. |
