RootMend MRR

The RootMend MRR is a meniscal root repair device composed of uncoated ultra-high molecular weight polyethylene (UHMWPE) with a titanium or all-suture fixation button. It is intended for suture fixation to bone in the knee for meniscal root repair procedures. The device is provided sterile via ethylene oxide sterilization for single use only.

The RootMend MRR features an adjustable loop design with either a titanium (Ti6Al-4V) button or an all-suture soft button for bone fixation, as opposed to the predicate's anchor body design. The UHMWPE material is available in undyed (white), black, or blue variants with colored trace filaments. These differences are acknowledged as minor and fall within the range of currently marketed comparable devices.

ISO 14937:2009 (sterilization validation), ISO 10993-7:2008 (ethylene oxide sterilization residuals biocompatibility), ISO 10993-1:2009 (general biocompatibility evaluation), ISO 11607-1:2006 (packaging for terminally sterilized devices), and EN 62366-1 (usability engineering). LAL and rabbit pyrogenicity testing were also performed.

The RootMend MRR performs the same soft tissue-to-bone fixation function as the predicate Arthrex SwiveLock and operates within identical indications for use. Although the subject device uses an adjustable loop with a soft button instead of an anchor body, non-clinical testing demonstrates equivalent fixation strength via cyclic and ultimate tensile strength testing. The minor design differences are established within the range of currently marketed alternatives and do not raise safety or effectiveness concerns.