510(k) · Cleared
ClearedCoapt Endotine Chin 3.5 Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coapt Systems, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 18, 2003 as substantially equivalent to K014153 (Coapt Systems, Inc., 2002) and 2 other predicates after a 41-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it.
- Decided
- Dec 18, 2003
- Review
- 41 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K014153 (2002). 3 ancestors in all, the oldest K974309 (1998). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 1 generation backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- This deviceK033524 Coapt Endotine Chin 3.5 DeviceCoapt Systems, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK040740 Endotine Transbleph DeviceCoapt Systems, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK060248 Ultratine TransblephCoapt Systems, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK042796 Endotine Transbleph 3.0/3.5 DeviceCoapt Systems, Inc. · 2004 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −1 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| 0 (this device) | K033524 | Coapt Endotine Chin 3.5 Device | Coapt Systems, Inc. | 2003 | — |
| +1 | K040740 | Endotine Transbleph Device | Coapt Systems, Inc. | 2004 | — |
| +2 | K060248 | Ultratine Transbleph | Coapt Systems, Inc. | 2006 | — |
| +1 | K042796 | Endotine Transbleph 3.0/3.5 Device | Coapt Systems, Inc. | 2004 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K014153 | Coapt Systmes Endotine DeviceSummary page 2…510(k) or PMA Number ENDOT[NE Forehead TM Coapt Systems, Inc K014153/K023992 Device Lactosorb® Panels Walter Lorenz Surgical K974309 DEVICE DESCRIPTION The ENDOTINE Ch… | 2002 |
| * | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 Our reading of the summary gave K023992, FDA’s number for Wiener Lab Colinesterasa AA (Wiener Laboratories Saic). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ENDOTINE Forehead Device”. | 2002 |
| * | K974309 | Lactosorb PanelsSummary page 2…Number ENDOT[NE Forehead TM Coapt Systems, Inc K014153/K023992 Device Lactosorb® Panels Walter Lorenz Surgical K974309 DEVICE DESCRIPTION The ENDOTINE ChinTM 3.5 Device kit consists of the chin implant with insertion tool and a drill bit. The Ch… | 1998 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1 year and passes through 1 company; a new generation was cleared every 12 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040740 (Coapt Systems, Inc., 2004) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K014153.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The ENDOTINE Chin TM 3.5 is intended for use in subperiosteal chinplasty surgery. The ENDOTINE ChinTM 3.5 is specifically indicated for use to fixate the subdermis to the mentum in chinplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033524: Coapt Endotine Chin 3.5 Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033524
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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