510(k) · Cleared
ClearedOptimized Barb Design
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 6, 2005 as substantially equivalent to K041593 (Surgical Specialties Corp, 2004) and 5 other predicates after a 46-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Dec 6, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K014153 (2002). 17 ancestors in all, the oldest K915489 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 5 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 4 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 3 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 2 generations backK042856 Contour Forehead/Browlift ThreadSurgical Specialties Corp · 2004
- 1 generation backK050247 Contour Necklift ThreadsSurgical Specialties Corp · 2005
- This deviceK052962 Optimized Barb DesignSurgical Specialties Corp · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −5 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −4 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −3 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −2 | K042856 | Contour Forehead/Browlift Thread | Surgical Specialties Corp | 2004 | — |
| −1 | K050247 | Contour Necklift Threads | Surgical Specialties Corp | 2005 | — |
| 0 (this device) | K052962 | Optimized Barb Design | Surgical Specialties Corp | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K041593 | Featherlift Extended Length Aptos ThreadSummary page 1…on1 / USUal (GAW Classification Name: Suture. Non Absorbable, Synthetic, Polypropylene Predicate Device: Contour Threads K04 1593, K05054 S. K050247 and K042856 as prevouIUSV submPitted by Surgical… | 2004 |
| * | K050548 | Contour Midface Opposing Uni-Directional ThreadsSummary page 1…oved Contour Threcad 510O (k's: K04 1593 Midthce Extendled Len,_zth K050548 Midface Opposing U ni-di rectional K050247 Neck Lilt K042856… | 2005 |
| * | K050247 | Contour Necklift ThreadsSummary page 1…(GAW Classification Name: Suture. Non Absorbable, Synthetic, Polypropylene Predicate Device: Contour Threads K04 1593, K05054 S. K050247 and K042856 as prevouIUSV submPitted by Surgical Specialties… | 2005 |
| * | K042856 | Contour Forehead/Browlift ThreadSummary page 1…Suture. Non Absorbable, Synthetic, Polypropylene Predicate Device: Contour Threads K04 1593, K05054 S. K050247 and K042856 as prevouIUSV submPitted by Surgical Specialties Corporation and… | 2004 |
| * | K042075 | Quill Synthetic Absorbable Barbed SutureSummary page 1…and K042856 as prevouIUSV submPitted by Surgical Specialties Corporation and Predicate K042075 and KOS 160119 as subDmitted by QUIll Medical for Barb desire. Indications For [Ise:… | 2004 |
| * | K051609 | Quill Synthetic Absorbable Barbed SutureSummary page 2…The Contour Thread barb design is the same as the Quill design approved in the 510(k) K042075 and K051609 The Contour Thread Optimized Barb Design Surgical Specialties Corporation DEPARTMENT OF HEALTH & HUMAN SER… | 2005 |
| † | P870064 | Surgical Specialties' Polypropylene Surgical Sutures |
What descends from it?
No later submission names this one as a predicate yet.
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 3 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 4 of the 17 ancestors have a recall of any class.
- 4 other devices also cite its predicate K041593.
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 Necklift Threads™ are indicated for use in Necklift surgery. The Contour Necklift Threads™ are specifically indicated for use to fixate and Elevate the subdermis to the deep fascia of the retromastoid area. The Contour Midface Opposing Uni-Directional Threads ™ are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position. The Contour Forehead/Browlift Thread-,', is indicated for use in browplasty…
Read the full statement (112 words)
The Contour Necklift Threads™ are indicated for use in Necklift surgery. The Contour Necklift Threads™ are specifically indicated for use to fixate and Elevate the subdermis to the deep fascia of the retromastoid area.
The Contour Midface Opposing Uni-Directional Threads ™ are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
The Contour Forehead/Browlift Thread-,', is indicated for use in browplasty surgery. The Contour Forehead/Browlift Thread-,',' is specifically indicated for use to fix-ate the subdermis to the periosteum of the cranium in browplasty.
The Feathediffll~ Extended Length Aptos Thread is indicated for use in midface-suspension surgery to fiXa2te the cheek subdermis in an elevated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052962: Optimized Barb Design.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052962
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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