510(k) · Cleared

Recalled · Class II · 2017

Maxon** Sterile, Synthetic, Absorbable Suture

K990951510(k) TraditionalCleared Apr 1, 199910-day reviewClass II21 CFR 878.4493Recalls 1

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 · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Apr 1, 1999 after a 10-day review. The FDA summary names its predicate without a number. 36 later devices descend from it. It has been recalled once.

Decided: Apr 1, 1999
Review: 10 days
Class: Class II
Product code: GAM
Recalls: 1
Predicates: 0

36 later devices descend from it, 4 citing it directly.

This deviceK990951 Maxon** Sterile, Synthetic, Absorbable SutureUnited States Surgical, A Division of Tyco Healthc · 1999
Descendant · cites it directly · 34 of its ownK082662 V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009
Descendant · 2 generations on · 27 of its ownK091087 Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009 · Recalled
Descendant · 2 generations on · 25 of its ownK113744 Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech · 2012
Descendant · 3 generations on · 24 of its ownK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
Descendant · 3 generations on · 19 of its ownK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2005high 4 (2012) · low 0 (2006)2026

Most influential descendants

Showing 5 of 36 · See all

K082662V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009 · cites it directly34descendants
K091087Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009 · 2 generations on27descendants
K113744Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech · 2012 · 2 generations on25descendants
K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · 3 generations on24descendants
K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990951	Maxon** Sterile, Synthetic, Absorbable Suture	United States Surgical, A Division of Tyco Healthc	1999	—
+1	K082662	V-Loc 180 Absorbable Wound Closure Device	Surgical Devices, Tyco Healthcare Group LP	2009	—
+2	K091087	Modification to V-Loc 180 Absorbable Wound Closure Device	Surgical Devices, Tyco Healthcare Group LP	2009	1
+2	K113744	Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)	Angiotech	2012	—
+3	K100257	VLOC9ABSORBABLE Wound Closure Device	Surgical Devices, A Division of Tyco Healthcare	2010	1
+3	K122898	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp. Dba Angiotech	2012	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	3	0
2010	1	0
2011	1	0
2012	4	0
2013	4	0
2014	1	0
2015	3	0
2016	1	0
2018	1	0
2019	2	0
2020	2	0
2021	2	0
2022	3	0
2023	1	0
2024	2	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K990951, 1999–2026Source: 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 GAM? 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 GAM device

#1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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? (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
*	—	Maxon Named without a submission number			—

What descends from it? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K082662	V-Loc 180 Absorbable Wound Closure Device	Surgical Devices, Tyco Healthcare Group LP	2009	34
K211792	StitchKit	Origami Surgical Inc .	2021	1
K093408	V-Loc 180 Absorbable Wound Closure Device	Surgical Devices, A Division of Tyco Healthcare	2009	0
K041515	Truglyde Absorbable Polyglycolic Acid Surgical Suture	Sutures India Private Limited	2005	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 3, 2017	Class II	Z-2542-2017	Process control	Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K082662 (Surgical Devices, Tyco Healthcare Group LP, 2009) has gone furthest, with 34 descendants of its own.

How does its category compare?

All GAM devices

GAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAM

3in 2025

2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007high 209 (2015) · low 10 (2009)2026

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

Recalls per year · GAM

1in 2024

2007high 44 (2020) · low 0 (2012)2026

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

Adverse event reports per year · GAM

8,970in 2025

2007high 8,970 (2025) · low 194 (2008)2025

MAUDE reports naming product code GAM, 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	7	50	10	274
2008	6	174	1	194
2009	3	10	6	287
2010	1	—	3	587
2011	2	—	6	637
2012	5	31	0	868
2013	1	—	0	898
2014	10	121	0	1,410
2015	5	209	0	935
2016	3	169	1	1,112
2017	8	134	1	1,499
2018	5	98	0	2,229
2019	4	90	1	3,564
2020	3	140	44	3,415
2021	2	—	0	4,506
2022	2	—	4	4,814
2023	1	—	0	5,070
2024	2	—	1	7,226
2025	3	29	0	8,970
2026	4	131	2	—

What is it indicated for?

Maxon and Maxon CV sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular 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/K990951 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990951: Maxon** Sterile, Synthetic, Absorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990951

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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