# K234079: HyperSuture Extension Line

- Pathway: 510(k) (Traditional)
- Applicant: Threadstone, LLC
- Decided: May 10, 2024 after 140 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K990088 (1999). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230311: HyperSuture, Threadstone, LLC (2023) Summary page 4.

## Indications for use
HyperSuture Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

Source page: https://510kreport.com/device/K234079
Methodology: https://510kreport.com/methodology