# K230311: HyperSuture

- Pathway: 510(k) (Traditional)
- Applicant: Threadstone, LLC
- Decided: Nov 24, 2023 after 294 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: 7 generations back to K990088 (1999). 37 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181774: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture, Teleflex Medical Incorporated (2018) Summary page 5.

## Most influential descendants
- K242201: HyperSuture White/Green Extension Line (2025), 1 descendant of its own
- K254275: HyperSuture All Green Extension Line (2026), 0 descendants of its own
- K241376: HyperSuture All Blue Extension Line (2024), 0 descendants of its own
- K234079: HyperSuture Extension Line (2024), 0 descendants of its own

## Indications for use
HyperSuture sutures (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/K230311
Methodology: https://510kreport.com/methodology