510(k) · Cleared
ClearedCytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteogenics Biomedical, Inc. · NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Cleared on Nov 24, 2000 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Nov 24, 2000
- Review
- 57 days
- Class
- Class II
- Product code
- NBY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK003028 Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC…Osteogenics Biomedical, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK163049 GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures · 2017
- Descendant · 2 generations on · 0 of its ownK192088 GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003028 | Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | Osteogenics Biomedical, Inc. | 2000 | — |
| +1 | K163049 | GOLNIT Non-Absorbable PTFE Surgical Suture | Antarma Dba Golnit Sutures | 2017 | — |
| +2 | K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC Dba Golnit Sutures | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NBY device
- #1 K231277 TissueStatscore 6.9 · 3 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163049 | GOLNIT Non-Absorbable PTFE Surgical Suture | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163049 (Antarma Dba Golnit Sutures, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NBY devicesNBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NBY
58in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBY
No recall names NBY since 2007.
Adverse event reports per year · NBY
1in 2025
MAUDE reports naming product code NBY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 161 | 0 | 0 |
| 2018 | 4 | 99 | 0 | 0 |
| 2019 | 3 | 58 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003028: Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003028
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026