# K253693: Strut Suture; No-Tie Button

- Pathway: 510(k) (Traditional)
- Applicant: Riverpoint Medical, LLC
- Decided: Mar 11, 2026 after 110 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: 9 generations back to K904436 (1990). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202581: Arthrex TightRope II, Arthrex, Inc. (2020) Summary page 5.
- K151342: Arthrex SwiveLock Anchors, Arthrex, Inc. (2016) Summary page 7.

## Indications for use
The Strut Suture is intended to be used for fixation of bone to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in ACL/PCL Repair. The No-Tie Button is intended to be used for fixation of bone to bone, intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in ACL/PCL Repair when used with Strut Suture (or equivalent) and soft tissue fixation to bone in the knee for meniscal root repair when used with RootMend MRR (or equivalent).

Source page: https://510kreport.com/device/K253693
Methodology: https://510kreport.com/methodology