510(k) · Cleared
ClearedContour Midface Opposing Uni-Directional Threads
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 Apr 1, 2005 as substantially equivalent to K041593 (Surgical Specialties Corp, 2004) after a 30-day review. Its family tree reaches back 4 generations to 2002. 65 later devices descend from it.
- Decided
- Apr 1, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K014153 (2002). 5 ancestors in all, the oldest K974309 (1998). 65 later devices descend from it, 3 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 deviceK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- Descendant · cites it directly · 64 of its ownK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- Descendant · 2 generations on · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- Descendant · 2 generations on · 30 of its ownK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- Descendant · 2 generations on · 29 of its ownK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- Descendant · 2 generations on · 26 of its ownK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005 · cites it directly64descendants
- K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · 2 generations on31descendants
- K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008 · 2 generations on30descendants
- K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008 · 2 generations on29descendants
- K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007 · 2 generations on26descendants
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) | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| +1 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| +2 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| +2 | K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone | Surgical Specialties Corp | 2008 | — |
| +2 | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) | Surgical Specialties Corp | 2008 | — |
| +2 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
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 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 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 | 1 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041593 | Featherlift Extended Length Aptos ThreadSummary page 1…Classification Name: Suture, Non Absorbable, Synthetic, Polypropylene Predicate Device: Contour Extended Length Threads K041593 Indications For Use: The Contour Midface Opposing Uni-directional… | 2004 |
| † | P870064 | Polypropylene Surgical Sutures |
What descends from it? (65)
See all 653 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 3 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, K051609 (Quill Medical, Inc., 2005) has gone furthest, with 64 descendants of its own.
- 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 Midface Opposing Uni-Directional Threads are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050548: Contour Midface Opposing Uni-Directional Threads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050548
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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