# K072076: Cytoplast Ptfe Suture

- Pathway: 510(k) (Abbreviated)
- Applicant: Osteogenics Biomedical, Inc.
- Decided: Oct 31, 2007 after 93 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
No predicates in its family tree.
12 later devices descend from it; 7 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140415: Monotex (2014), 8 descendants of its own
- K173335: Gazelle PTFE and Suture Delivery Device (2018), 2 descendants of its own
- K160744: LOOK PTFE Suture (2016), 2 descendants of its own
- K170842: Wego-Ptfe (2017), 1 descendant of its own
- K233355: Cypris eXact Suturing System (2024), 0 descendants of its own

## Indications for use
The Cytoplast® PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

Source page: https://510kreport.com/device/K072076
Methodology: https://510kreport.com/methodology