New Test Methods for Implanted Meniscus Repair Devices
1. Scope
The work item is intended to create a test standard to determine the mechanical strength of "all-inside" meniscal repair surgical implants in both benchtop and ex vivo models.
Keywords
meniscus; cyclic displacement; maximum load; anchor and suture
Rationale
Numerous orthopedics device manufacturers have developed and marketed meniscal repair surgical implants, and while there are many different designs and styles of these implants currently available, many of the most widely used devices consist of two anchors with a connecting tensioning suture. Regulatory body submissions for these devices typically contain comparative mechanical testing to demonstrate substantial equivalence to existing implant constructs. This standard can be used by implant manufacturers to suggest controlled and repeatable mechanical testing methods to evaluate their devices.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 09-23-2025
Technical Contact: John Konicek
Item: 000
Ballot:
Status: