510(k) Report

510(k) · Cleared

Cleared

Coapt Systems Endotine Device, Model CFD-101-00197

K023922510(k) SpecialCleared Dec 20, 200225-day reviewClass II21 CFR 888.3040

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

Coapt Systems, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 20, 2002 as substantially equivalent to K014153 (Coapt Systems, Inc., 2002) after a 25-day review. Its family tree reaches back 1 generation to 2002. 81 later devices descend from it.

Decided
Dec 20, 2002
Review
25 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K014153 (2002). 81 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2004: 6 descendants cleared2003: 2 descendants cleared2006: 4 descendants cleared2005: 7 descendants cleared2009: 2 descendants cleared2023: 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 clearedK014153 · Coapt Systmes Endotine Device · Coapt Systems, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 4 descendants5 generations forward: 16 descendants6 generations forward: 25 descendants7 generations forward: 14 descendants8 generations forward: 7 descendants9 generations forward: 1 descendant K014153 · Coapt Systmes Endotine Device · Coapt Systems, Inc. · 20020+5
  1. Root · 1 generation backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
  2. This deviceK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
  3. Descendant · cites it directly · 74 of its ownK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
  4. Descendant · 2 generations on · 72 of its ownK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
  5. Descendant · 3 generations on · 65 of its ownK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
  6. Descendant · 4 generations on · 64 of its ownK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
  7. Descendant · 5 generations on · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2003: 22004: 62005: 72006: 42007: 22008: 32009: 22010: 12011: 12012: 62013: 62014: 22015: 42016: 22017: 12018: 42019: 62020: 42021: 32022: 32023: 22024: 42025: 32026: 3
2003high 7 (2005) · low 1 (2010)2026

Most influential descendants

Showing 5 of 81 · See all
  • K032698Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003 · cites it directly74descendants
  • K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004 · 2 generations on72descendants
  • K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005 · 3 generations on65descendants
  • K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005 · 4 generations on64descendants
  • K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · 5 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K014153Coapt Systmes Endotine DeviceCoapt Systems, Inc.2002—
0 (this device)K023922Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc.2002—
+1K032698Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc.2003—
+2K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp2004—
+3K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp2005—
+4K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.2005—
+5K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200460
200570
200640
200720
200830
200920
201010
201110
201260
201360
201420
201540
201620
201710
201840
201960
202040
202130
202230
202320
202440
202530
202630
FIG. 1 — Lineage of K023922, 2002–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 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
*K014153Coapt Systmes Endotine DeviceCoapt Systems, Inc.2002—

Also cleared against K014153: 7 other devices →

What descends from it? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K032698Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc.200374
K033524Coapt Endotine Chin 3.5 DeviceCoapt Systems, Inc.20033
K040740Endotine Transbleph DeviceCoapt Systems, Inc.20042
K060249Ultratine ForeheadCoapt Systems, Inc.20060
K042796Endotine Transbleph 3.0/3.5 DeviceCoapt Systems, Inc.20040
K042078Endotine Forehead Triple DeviceCoapt Systems, Inc.20040

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?

  • Its one ancestor has no recall.
  • Of its descendants, K032698 (Coapt Systems, Inc., 2003) has gone furthest, with 74 descendants of its own.
  • 7 other devices also cite its predicate K014153.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The ENDOTINE Device is intended for use in browplasty surgery. The ENDOTINE device is specifically intended for use to fixate the subdermis to the cranial bone in browplasty procedures.

Indications for use as stated in the FDA summary.

Also cleared against K014153

7 other devices cite the same predicate.

  • K042856Contour Forehead/Browlift ThreadSurgical Specialties Corp · 2004
  • K042796Endotine Transbleph 3.0/3.5 DeviceCoapt Systems, Inc. · 20041 recall
  • K042078Endotine Forehead Triple DeviceCoapt Systems, Inc. · 2004
  • K040740Endotine Transbleph DeviceCoapt Systems, Inc. · 2004
  • K033524Coapt Endotine Chin 3.5 DeviceCoapt Systems, Inc. · 2003
  • K032698Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003

More from Coapt Systems, Inc.

17 FDA decisions under this applicant name. See the company

  • K083783VF LiquigelCoapt Systems, Inc. · 2009
  • K080956Modification to VF Gel PlusCoapt Systems, Inc. · 2008
  • K071663VF Gel PlusCoapt Systems, Inc. · 2008
  • K060248Ultratine TransblephCoapt Systems, Inc. · 2006
  • K060249Ultratine ForeheadCoapt Systems, Inc. · 2006

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K023922 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023922: Coapt Systems Endotine Device, Model CFD-101-00197.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023922

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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