# K243988: RootMend MRR

- Pathway: 510(k) (Traditional)
- Applicant: Riverpoint Medical, LLC
- Decided: Mar 20, 2025 after 84 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 RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.

Source page: https://510kreport.com/device/K243988
Methodology: https://510kreport.com/methodology