# K231404: T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button

- Pathway: 510(k) (Traditional)
- Applicant: Healthium Medtech Limited
- Decided: Aug 4, 2023 after 81 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: 10 generations back to K904436 (1990). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221128: Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II, Arthrex, Inc. (2022) Summary page 5.

## Indications for use
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button are to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. This device is employed in Knee ligament repair and reconstructive procedures, specifically for ACL/PCL repair and reconstruction.

Source page: https://510kreport.com/device/K231404
Methodology: https://510kreport.com/methodology