# K240835: Suture Button Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Jul 19, 2024 after 115 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: 13 generations back to K792022 (1979). 59 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171060: OrthoButton AL, Riverpoint Medical (2017) Summary page 4.

## Most influential descendants
- K261770: Suture Button Repair System (2026), 0 descendants of its own

## Indications for use
The Suture Button Repair System is intended for fixation of bone and soft tissue in upper extremity orthopedic procedures requiring ligament or tendon reconstruction in the hand, wrist, forearm, elbow and shoulder.

Source page: https://510kreport.com/device/K240835
Methodology: https://510kreport.com/methodology