510(k) Report

510(k) · Cleared

Cleared

Quill Synthetic Absorbable Barbed Suture

K042075510(k) TraditionalCleared Oct 26, 200485-day reviewClass II21 CFR 878.4840

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

Quill Medical, Inc. · NEW Suture, Surgical, Absorbable, Polydioxanone

Cleared on Oct 26, 2004 after an 85-day review. The FDA summary names its predicate without a number. 68 later devices descend from it.

Decided
Oct 26, 2004
Review
85 days
Class
Class II
Product code
NEW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 3 descendants cleared2005: 4 descendants cleared2013: 6 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2012: 6 descendants cleared2008: 3 descendants cleared2018: 4 descendants cleared2011: 2 descendants cleared2016: 2 descendants cleared2015: 4 descendants cleared2017: 1 descendant cleared2026: 3 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2019: 6 descendants cleared2020: 4 descendants cleared2021: 3 descendants cleared2022: 3 descendants cleared2024: 4 descendants cleared2025: 3 descendants cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK042075 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2004
  2. Descendant · cites it directly · 64 of its ownK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
  3. Descendant · cites it directly · 34 of its ownK082662 V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009
  4. Descendant · 2 generations on · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
  5. Descendant · 2 generations on · 30 of its ownK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
  6. Descendant · 2 generations on · 29 of its ownK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2005: 42006: 12007: 22008: 32009: 32010: 12011: 22012: 62013: 62014: 22015: 42016: 22017: 12018: 42019: 62020: 42021: 32022: 32023: 12024: 42025: 32026: 3
2005high 6 (2012) · low 1 (2006)2026

Most influential descendants

Showing 5 of 68 · See all
  • K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005 · cites it directly64descendants
  • K082662V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009 · cites it directly34descendants
  • K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · 2 generations on31descendants
  • K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008 · 2 generations on30descendants
  • K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008 · 2 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042075Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.2004—
+1K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.2005—
+1K082662V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP2009—
+2K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp2007—
+2K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp2008—
+2K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200540
200610
200720
200830
200930
201010
201120
201260
201360
201420
201540
201620
201710
201840
201960
202040
202130
202230
202310
202440
202530
202630
FIG. 1 — Lineage of K042075, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 NEW? 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 NEW device

  1. #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*—PDS II, a Synthetic Monofilament Absorbable Suture
Named without a submission number
—

What descends from it? (68)

See all 68

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

NumberDeviceApplicantDecidedDescendants
K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.200564
K082662V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP200934
K130191MINTHans Biomed Corporation20135
K052962Optimized Barb DesignSurgical Specialties Corp20050

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, K051609 (Quill Medical, Inc., 2005) has gone furthest, with 64 descendants of its own.

How does its category compare?

All NEW devices

NEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NEW

6in 2025

2007: 22008: 52010: 32011: 12012: 32013: 52014: 12015: 22016: 32017: 12018: 32019: 42020: 32021: 12022: 12023: 12024: 32025: 62026 (partial year): 5
2007high 6 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEW

146in 2025

2008: 22 days median2010: 270 days median2012: 113 days median2013: 32 days median2016: 254 days median2018: 441 days median2019: 144 days median2020: 230 days median2024: 48 days median2025: 146 days median2026 (partial year): 264 days median
2007high 441 (2018) · low 22 (2008)2026

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

Recalls per year · NEW

1in 2022

2008: 12009: 42012: 12013: 12014: 12019: 22022: 1
2007high 4 (2009) · low 0 (2007)2026

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

Adverse event reports per year · NEW

2,504in 2025

2007: 72008: 292009: 422010: 1152011: 592012: 822013: 1852014: 2742015: 2802016: 3212017: 4612018: 9002019: 1,1222020: 1,0102021: 1,4662022: 1,5372023: 1,9752024: 2,1142025: 2,504
2007high 2,504 (2025) · low 7 (2007)2025

MAUDE reports naming product code NEW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—07
2008522129
20090—442
201032700115
20111—059
20123113182
20135321185
20141—1274
20152—0280
201632540321
20171—0461
201834410900
2019414421,122
2020323001,010
20211—01,466
20221—11,537
20231—01,975
202434802,114
2025614602,504
202652640—

What is it indicated for?

QuillTM Synthetic Absorbable Barbed Sutures are indicated to close easily approximated edges of dermis where use of absorbable sutures is appropriate.

Indications for use as stated in the FDA summary.

More from Quill Medical, Inc.

4 FDA decisions under this applicant name. See the company

  • K052900Quill Nonabsorbable Nylon Barbed SutureQuill Medical, Inc. · 2005
  • K052373Quill Nonabsorbable Polypropylene Barbed SutureQuill Medical, Inc. · 2005
  • K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005

Recent decisions in NEW

The NEW category page

  • K254238MINT MONO SuturesHans Biomed Corporation · 2026
  • K253879Monofix PdoSamyang Holdings Corporation · 2026
  • K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC · 2026
  • K252171Barbed PDO SutureSutura Medical Technology, Inc. · 2026
  • K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc. · 2026

https://510kreport.com/device/K042075 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042075: Quill Synthetic Absorbable Barbed Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042075

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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