510(k) · Cleared

Recalled · Class II · 2026

Modification to: Modified Uss Polypropylene Suture

K050947510(k) SpecialCleared Jun 1, 200547-day reviewClass II21 CFR 878.5010Recalls 2

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

United States Surgical, A Division of Tyco Healthc · GAW Suture, Nonabsorbable, Synthetic, Polypropylene

Cleared on Jun 1, 2005 as substantially equivalent to K954808 (United States Surgical, A Division of Tyco Healthc, 1996) and 1 other predicate after a 47-day review. Its family tree reaches back 1 generation to 1996. 76 later devices descend from it. It has been recalled 2 times.

Decided: Jun 1, 2005
Review: 47 days
Class: Class II
Product code: GAW
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K954808 (1996). 2 ancestors in all. 76 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK954808 Ussc Polyproplene SutureUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
This deviceK050947 Modification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc · 2005
Descendant · cites it directly · 69 of its ownK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
Descendant · 2 generations on · 29 of its ownK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
Descendant · 2 generations on · 23 of its ownK070673 Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007
Descendant · cites it directly · 15 of its ownK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010 · Recalled
Descendant · 2 generations on · 14 of its ownK150438 Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2007high 10 (2015) · low 0 (2008)2026

Most influential descendants

Showing 5 of 76 · See all

K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · cites it directly69descendants
K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef · 2009 · 2 generations on29descendants
K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007 · 2 generations on23descendants
K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical · 2010 · cites it directly15descendants
K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015 · 2 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954808	Ussc Polyproplene Suture	United States Surgical, A Division of Tyco Healthc	1996	1
0 (this device)	K050947	Modification to: Modified Uss Polypropylene Suture	United States Surgical, A Division of Tyco Healthc	2005	—
+1	K063778	Force Fiber Polyethylene Nonabsorbable Suture	Teleflex Medical	2007	1
+2	K092533	Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures	Beere Precision Medical Instruments, Kmedic, Telef	2009	—
+2	K070673	Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture	Teleflexmedical, Inc.	2007	—
+1	K100006	HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)…	Riverpoint Medical	2010	2
+2	K150438	Force Fiber OrthoTape suture	Teleflexmedical, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	3	0
2009	3	0
2010	3	0
2012	3	0
2013	4	0
2014	4	0
2015	10	0
2016	4	0
2017	4	0
2018	6	0
2019	4	0
2020	4	0
2021	3	0
2022	1	0
2023	4	0
2024	6	0
2025	4	0
2026	6	0

FIG. 1 — Lineage of K050947, 1996–2026Source: 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 GAW? 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 GAW device

#1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K954808	Ussc Polyproplene Suture Summary page 1 …Modified USS Polypropylene Suture PROPRIETARY NAME: To be determined PREDICATE DEVICES: USSC Polypropylene Suture (K954808) Modified USS Polypropylene Suture (KO 10909) INTENDED USE:…	United States Surgical, A Division of Tyco Healthc	1996	1
*	K010909	Nonabsorbable Polypropylene Surgical Suture	Tyco Healthcare Group LP	2001	—

Also cleared against K954808: 1 other device →

What descends from it? (76)

See all 76

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063778	Force Fiber Polyethylene Nonabsorbable Suture	Teleflex Medical	2007	69
K100006	HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…	Riverpoint Medical	2010	15
K133890	Aesculap Optilene Nonabsorbable Suture	Aesculap, Inc.	2014	5

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 24, 2026	Class II	Z-2922-2026	Equipment maintenance	Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Dec 2, 2022	Class II	Z-1180-2023	Packaging process control	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K063778 (Teleflex Medical, 2007) has gone furthest, with 69 descendants of its own.
1 other device also cites its predicate K954808.

How does its category compare?

All GAW devices

GAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAW

1in 2024

2007high 3 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAW

80in 2018

2007high 252 (2015) · low 36 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAW

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAW

2,545in 2025

2007high 2,545 (2025) · low 71 (2009)2025

MAUDE reports naming product code GAW, 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	—	1	73
2008	0	—	0	75
2009	0	—	0	71
2010	2	—	0	85
2011	0	—	0	84
2012	3	86	0	194
2013	3	36	0	191
2014	2	—	0	437
2015	3	252	0	422
2016	1	—	0	440
2017	3	145	0	413
2018	3	80	0	685
2019	1	—	0	1,803
2020	2	—	0	1,493
2021	0	—	0	1,652
2022	2	—	0	1,563
2023	1	—	0	1,811
2024	1	—	0	2,348
2025	0	—	0	2,545
2026	1	—	2	—

What is it indicated for?

Modified USS polypropylene sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050947 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050947: Modification to: Modified Uss Polypropylene Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050947

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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