# K003028: Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Biomedical, Inc.
- Decided: Nov 24, 2000 after 57 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K163049: GOLNIT Non-Absorbable PTFE Surgical Suture (2017), 1 descendant of its own
- K192088: GOLNIT Non-aborbable PTFE Surgical Suture (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K003028
Methodology: https://510kreport.com/methodology