| K-number | K253695 |
| Device name | LigaMend |
| Applicant | Riverpoint Medical, LLC |
| Product code | MBI |
| Device class | Class II |
| Decision date | Feb 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
LigaMend is a fixation loop made of ultra-high molecular weight polyethylene (UHMWPE) with either a titanium or UHMWPE button anchor, designed to fix soft tissue to bone during ligament and tendon repair procedures in the shoulder, foot/ankle, and knee.
The device features an adjustable UHMWPE loop with a titanium (Ti-6Al-4V) button or all-suture soft button anchor. These minor design differences (adjustable loop and button material options) fall within the range of currently marketed predicate devices and do not raise safety or effectiveness concerns.
ISO 14937:2009 (sterilization validation), ISO 10993-7:2008 (ethylene oxide sterilization residuals), ISO 10993-1:2009 (biocompatibility), ISO 11607-1:2006 (packaging for sterilized devices), EN 62366-1 (usability engineering), plus LAL and rabbit pyrogenicity testing.
LigaMend is substantially equivalent to the predicate Arthrex SwiveLock (K203495) because it shares the same intended use, similar principles of operation, and similar technical characteristics for soft tissue-to-bone fixation. Non-clinical mechanical testing demonstrated equivalent fixation strength, and the minor design differences are within the range of currently marketed devices.
View the full FDA submission: accessdata.fda.gov