1. Scope

Keywords

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.