# K253695: LigaMend

- Pathway: 510(k) (Traditional)
- Applicant: Riverpoint Medical, LLC
- Decided: Feb 27, 2026 after 98 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K792022 (1979). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203495: Arthrex SwiveLock Anchor, Arthrex, Inc. (2021) Summary page 5.

## Indications for use
The LigaMend devices are intended to be used for fixation of soft tissue to bone and are intended as fixation over areas of ligament or tendon repair, in the following procedures: • Shoulder: Biceps Tenodesis, Acromio-Clavicular Separation Repair • Foot/Ankle: Achilles Tendon Repair. • Knee: Meniscal Root Repair, MPFL Repair, ACUPCL repair

Source page: https://510kreport.com/device/K253695
Methodology: https://510kreport.com/methodology