510(k) · Cleared
ClearedCoapt Endotine Midface-ST 4.5 Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coapt Systems, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Oct 23, 2003 as substantially equivalent to K023922 (Coapt Systems, Inc., 2002) and 2 other predicates after a 51-day review. Its family tree reaches back 2 generations to 2002. 74 later devices descend from it.
- Decided
- Oct 23, 2003
- Review
- 51 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K014153 (2002). 3 ancestors in all, the oldest K974309 (1998). 74 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 deviceK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- Descendant · cites it directly · 72 of its ownK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- Descendant · 2 generations on · 65 of its ownK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- Descendant · 3 generations on · 64 of its ownK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- Descendant · 4 generations on · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- Descendant · 4 generations on · 30 of its ownK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004 · cites it directly72descendants
- K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005 · 2 generations on65descendants
- K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005 · 3 generations on64descendants
- K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · 4 generations on31descendants
- K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008 · 4 generations on30descendants
View 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) | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| +1 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| +2 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| +3 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| +4 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| +4 | K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone | Surgical Specialties Corp | 2008 | — |
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 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 Our OCR of the scanned summary read 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 |
| * | K014153 | Coapt Systmes Endotine DeviceSummary page 2…ARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED Name of Predicate Device | Name of Manufacturer 510(k) or PMA Number ENDOTINE Forehead™ Coapt Systems, Inc K023992/K014153 Device PDS II Suture Ethicon, Inc. N18331 Lactosorb® Panels Walter Lorenz Surgical K974309 DEVICE DESCRIPTION The ENDOTINE Midfa… | 2002 |
| * | K974309 | Lactosorb PanelsSummary page 2…anufacturer 510(k) or PMA Number ENDOTINE Forehead™ Coapt Systems, Inc K023992/K014153 Device PDS II Suture Ethicon, Inc. N18331 Lactosorb® Panels Walter Lorenz Surgical K974309 DEVICE DESCRIPTION The ENDOTINE Midface™.-ST 4.5 consists of insertion tools and bioabsorbable implants. The device implant cons… | 1998 |
| * | — | PDS II Suture Named without a submission number |
What descends from it? (74)
See all 742 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 10 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041593 (Surgical Specialties Corp, 2004) has gone furthest, with 72 descendants of its own.
- 5 other devices also cite its predicate K023922.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 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?
The ENDOTINE Midface™-ST 4.5 is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
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/K032698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032698: Coapt Endotine Midface-ST 4.5 Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032698
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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