510(k) · Cleared

Cleared

C-PTFETM Surgical Suture

K173922510(k) TraditionalCleared Mar 26, 201890-day reviewClass II21 CFR 878.5035

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cp Medical, Inc. · NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Cleared on Mar 26, 2018 as substantially equivalent to K140415 (Riverpoint Medical, 2014) after a 90-day review. Its family tree reaches back 2 generations to 2007.

Decided: Mar 26, 2018
Review: 90 days
Class: Class II
Product code: NBY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K072076 (2007). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK072076 Cytoplast Ptfe SutureOsteogenics Biomedical, Inc. · 2007
1 generation backK140415 MonotexRiverpoint Medical · 2014
This deviceK173922 C-PTFETM Surgical SutureCp Medical, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K072076	Cytoplast Ptfe Suture	Osteogenics Biomedical, Inc.	2007	—
−1	K140415	Monotex	Riverpoint Medical	2014	—
0 (this device)	K173922	C-PTFETM Surgical Suture	Cp Medical, Inc.	2018	—

FIG. 1 — Lineage of K173922, 2007–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K140415	Monotex Summary page 4 …Common Name Surgical Suture, Nonabsorbable Code –Name – NBY – Surgical Suture Class II: 21 CFR §878.5035 Classification Predicate Devices MonoTex K140415 This predicate has not been subject to a design-related recall (FDA’s TPLC website,.…	Riverpoint Medical	2014	—

Also cleared against K140415: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K140415.

How does its category compare?

All NBY devices

NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · NBY

1in 2023

2007high 4 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBY

58in 2019

2007high 161 (2017) · low 58 (2019)2026

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

2007high 5 (2023) · low 0 (2007)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	MAUDE reports
2007	1	—	0
2008	0	—	1
2009	0	—	1
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	1	—	0
2014	2	—	0
2015	0	—	0
2016	1	—	0
2017	3	161	0
2018	4	99	0
2019	3	58	0
2020	0	—	0
2021	0	—	4
2022	0	—	4
2023	1	—	5
2024	0	—	3
2025	0	—	1
2026	0	—	—

What is it indicated for?

The CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K173922 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173922: C-PTFETM Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173922

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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