510(k) Report

510(k) · Cleared

Cleared

Featherlift Extended Length Aptos Thread

K041593510(k) TraditionalCleared Sep 20, 200498-day reviewClass II21 CFR 878.5010

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

Surgical Specialties Corp · GAW Suture, Nonabsorbable, Synthetic, Polypropylene

Cleared on Sep 20, 2004 as substantially equivalent to K032698 (Coapt Systems, Inc., 2003) after a 98-day review. Its family tree reaches back 3 generations to 2002. 72 later devices descend from it.

Decided
Sep 20, 2004
Review
98 days
Class
Class II
Product code
GAW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K014153 (2002). 4 ancestors in all, the oldest K974309 (1998). 72 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2004: 1 descendant cleared2005: 7 descendants cleared2009: 2 descendants cleared2023: 2 descendants cleared2006: 2 descendants cleared2007: 2 descendants cleared2013: 6 descendants cleared2012: 6 descendants cleared2008: 3 descendants cleared2018: 4 descendants cleared2017: 1 descendant cleared2026: 3 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2019: 6 descendants cleared2016: 2 descendants cleared2015: 4 descendants cleared2011: 1 descendant cleared2020: 4 descendants cleared2021: 3 descendants cleared2022: 3 descendants cleared2024: 4 descendants cleared2025: 3 descendants clearedReference device: K904906 · Sharpoint Polypropylene Nonabsorb Surg Sutures Usp · Chathamborough Research Group, Inc. · 1990 · recalledK014153 · Coapt Systmes Endotine Device · Coapt Systems, Inc. · 2002K023922 · Coapt Systems Endotine Device, Model CFD-101-00197 · Coapt Systems, Inc. · 2002K032698 · Coapt Endotine Midface-ST 4.5 Device · Coapt Systems, Inc. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 16 descendants4 generations forward: 25 descendants5 generations forward: 14 descendants6 generations forward: 7 descendants7 generations forward: 1 descendant K032698 · Coapt Endotine Midface-ST 4.5 Device · Coapt Systems, Inc. · 2003K023922 · Coapt Systems Endotine Device, Model CFD-101-00197 · Coapt Systems, Inc. · 2002K014153 · Coapt Systmes Endotine Device · Coapt Systems, Inc. · 20020+5
  1. Root · 3 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
  2. 2 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
  3. 1 generation backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
  4. This deviceK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
  5. Descendant · cites it directly · 65 of its ownK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
  6. Descendant · 2 generations on · 64 of its ownK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
  7. Descendant · 3 generations on · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
  8. Descendant · 3 generations on · 30 of its ownK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
  9. Descendant · 3 generations on · 29 of its ownK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2004: 12005: 72006: 22007: 22008: 32009: 22010: 12011: 12012: 62013: 62014: 22015: 42016: 22017: 12018: 42019: 62020: 42021: 32022: 32023: 22024: 42025: 32026: 3
2004high 7 (2005) · low 1 (2004)2026

Most influential descendants

Showing 5 of 72 · See all
  • K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005 · cites it directly65descendants
  • K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005 · 2 generations on64descendants
  • K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · 3 generations on31descendants
  • K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008 · 3 generations on30descendants
  • K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008 · 3 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K014153Coapt Systmes Endotine DeviceCoapt Systems, Inc.2002—
−2K023922Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc.2002—
−1K032698Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc.2003—
0 (this device)K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp2004—
+1K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp2005—
+2K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.2005—
+3K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp2007—
+3K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp2008—
+3K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200570
200620
200720
200830
200920
201010
201110
201260
201360
201420
201540
201620
201710
201840
201960
202040
202130
202230
202320
202440
202530
202630
FIG. 1 — Lineage of K041593, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

TypeNumberDeviceApplicantDecidedRecalls
*K032698Coapt Endotine Midface-ST 4.5 Device
Summary page 1
…GAW Classification Name: Suture, Non Absorbable, Synthetic, Polypropylene Predicate Device: Coapt Endotine Midface ST 4.5 device K032698 Indications For Use: Featherlift Aptos Extended Length Threads are indicated f…
Coapt Systems, Inc.2003—
†P870064Unnamed device—
†K904906Sharpoint Polypropylene Nonabsorb Surg Sutures UspChathamborough Research Group, Inc.19901

Also cleared against K032698: 1 other device →

What descends from it? (72)

See all 72

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

NumberDeviceApplicantDecidedDescendants
K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp200565
K042856Contour Forehead/Browlift ThreadSurgical Specialties Corp20044
K050247Contour Necklift ThreadsSurgical Specialties Corp20053
K091061Implicitguide Surgical Suture SystemImplicitcare, LLC20091
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?

  • The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 10 months on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K050548 (Surgical Specialties Corp, 2005) has gone furthest, with 65 descendants of its own.
  • 1 other device also cites its predicate K032698.

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

2007: 12010: 22012: 32013: 32014: 22015: 32016: 12017: 32018: 32019: 12020: 22022: 22023: 12024: 12026 (partial year): 1
2007high 3 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAW

80in 2018

2012: 86 days median2013: 36 days median2015: 252 days median2017: 145 days median2018: 80 days median
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

2007: 12026 (partial year): 2
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

2007: 732008: 752009: 712010: 852011: 842012: 1942013: 1912014: 4372015: 4222016: 4402017: 4132018: 6852019: 1,8032020: 1,4932021: 1,6522022: 1,5632023: 1,8112024: 2,3482025: 2,545
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—173
20080—075
20090—071
20102—085
20110—084
20123860194
20133360191
20142—0437
201532520422
20161—0440
201731450413
20183800685
20191—01,803
20202—01,493
20210—01,652
20222—01,563
20231—01,811
20241—02,348
20250—02,545
20261—2—

What is it indicated for?

The Featherlift™ Extended Length Aptos Thread is indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K041593: Featherlift Extended Length Aptos Thread.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041593

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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