510(k) · Cleared
ClearedContour Forehead/Browlift Thread
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Specialties Corp · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Dec 3, 2004 as substantially equivalent to K014153 (Coapt Systems, Inc., 2002) and 1 other predicate after a 60-day review. Its family tree reaches back 4 generations to 2002. 4 later devices descend from it.
- Decided
- Dec 3, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K014153 (2002). 5 ancestors in all, the oldest K974309 (1998). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 3 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 2 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 1 generation backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- This deviceK042856 Contour Forehead/Browlift ThreadSurgical Specialties Corp · 2004
- Descendant · cites it directly · 3 of its ownK050247 Contour Necklift ThreadsSurgical Specialties Corp · 2005
- Descendant · 2 generations on · 1 of its ownK051415 Endotine RibbonCoapt Systems, Inc. · 2005
- Descendant · 3 generations on · 0 of its ownK060828 Modification to Endotine RibbonCoapt Systems, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK052962 Optimized Barb DesignSurgical Specialties Corp · 2005
Most influential descendants
Showing 4 of 4 · See all- K050247Contour Necklift ThreadsSurgical Specialties Corp · 2005 · cites it directly3descendants
- K051415Endotine RibbonCoapt Systems, Inc. · 2005 · 2 generations on1descendant
- K060828Modification to Endotine RibbonCoapt Systems, Inc. · 2006 · 3 generations on0descendants
- K052962Optimized Barb DesignSurgical Specialties Corp · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −3 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −2 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −1 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| 0 (this device) | K042856 | Contour Forehead/Browlift Thread | Surgical Specialties Corp | 2004 | — |
| +1 | K050247 | Contour Necklift Threads | Surgical Specialties Corp | 2005 | — |
| +2 | K051415 | Endotine Ribbon | Coapt Systems, Inc. | 2005 | — |
| +3 | K060828 | Modification to Endotine Ribbon | Coapt Systems, Inc. | 2006 | — |
| +1 | K052962 | Optimized Barb Design | Surgical Specialties Corp | 2005 | — |
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 |
|---|---|---|
| 2005 | 3 | 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 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 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 1…GAW Classification Name: Suture, Non Absorbable, Synthetic, Polypropylene Predicate Device: Coapt Endotine Forehead Device K014153 Featherlift Extended Length Thread (Contour Threads TM) K04… | 2002 |
| * | K041593 | Featherlift Extended Length Aptos ThreadSummary page 1…Coapt Endotine Forehead Device K014153 Featherlift Extended Length Thread (Contour Threads TM) K041593 Indications For Use: The Contour Forehead/Browlift ThreadTM is indicated for u… | 2004 |
What descends from it? (4)
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 2 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K050247 (Surgical Specialties Corp, 2005) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K014153.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Contour Forehead / Browlift Thread TM is indicated for use in browplasty surgery.
The Contour Forehead / Browlift Thread TM is specifically indicated for use to fixate the subdermis to the periosteum of the Cranium in browplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042856 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042856: Contour Forehead/Browlift Thread.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042856
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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