510(k) · Cleared
ClearedCytoplast Ptfe Suture
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 Oct 31, 2007 after a 93-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Oct 31, 2007
- Review
- 93 days
- Class
- Class II
- Product code
- NBY
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 7 citing it directly.
- This deviceK072076 Cytoplast Ptfe SutureOsteogenics Biomedical, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK140415 MonotexRiverpoint Medical · 2014
- Descendant · 2 generations on · 2 of its ownK173335 Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC · 2018
- Descendant · cites it directly · 2 of its ownK160744 LOOK PTFE SutureSurgical Specialties Corporation · 2016
- Descendant · cites it directly · 1 of its ownK170842 Wego-PtfeFoosin Medical Supplies Inc., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK233355 Cypris eXact Suturing SystemCypris Medical · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K140415MonotexRiverpoint Medical · 2014 · cites it directly8descendants
- K173335Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC · 2018 · 2 generations on2descendants
- K160744LOOK PTFE SutureSurgical Specialties Corporation · 2016 · cites it directly2descendants
- K170842Wego-PtfeFoosin Medical Supplies Inc., Ltd. · 2017 · cites it directly1descendant
- K233355Cypris eXact Suturing SystemCypris Medical · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072076 | Cytoplast Ptfe Suture | Osteogenics Biomedical, Inc. | 2007 | — |
| +1 | K140415 | Monotex | Riverpoint Medical | 2014 | — |
| +2 | K173335 | Gazelle PTFE and Suture Delivery Device | Dura Tap, LLC | 2018 | — |
| +1 | K160744 | LOOK PTFE Suture | Surgical Specialties Corporation | 2016 | — |
| +1 | K170842 | Wego-Ptfe | Foosin Medical Supplies Inc., Ltd. | 2017 | — |
| +2 | K233355 | Cypris eXact Suturing System | Cypris Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 127 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K140415 (Riverpoint Medical, 2014) has gone furthest, with 8 descendants 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. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K072076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072076: Cytoplast Ptfe Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072076
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026