# K140415: Monotex

- Pathway: 510(k) (Abbreviated)
- Applicant: Riverpoint Medical
- Decided: Mar 26, 2014 after 36 days
- Product code: NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene)
- Device class: 2
- Regulation: 21 CFR 878.5035
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K072076 (2007). 1 ancestor in all.
8 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072076: Cytoplast Ptfe Suture, Osteogenics Biomedical, Inc. (2007) Summary page 1.

## Most influential descendants
- K173335: Gazelle PTFE and Suture Delivery Device (2018), 2 descendants of its own
- K160744: LOOK PTFE Suture (2016), 2 descendants of its own
- K233355: Cypris eXact Suturing System (2024), 0 descendants of its own
- K231277: TissueStat (2023), 0 descendants of its own
- K192088: GOLNIT Non-aborbable PTFE Surgical Suture (2019), 0 descendants of its own

## Indications for use
MonoTex PTFE surgical suture is indicated for use In general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the duna mater. MonoTex PTFE sutures are not Indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. MonoTex PTFE suture is provided sterile as a single use device,

Source page: https://510kreport.com/device/K140415
Methodology: https://510kreport.com/methodology