510(k) · Cleared
ClearedSmith & Newphew Ultrabraid II Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Newphew, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Apr 8, 2011 as substantially equivalent to K041216 (Smith & Nephew, Inc., 2004) after a 326-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Apr 8, 2011
- Review
- 326 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033654 (2004). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK033654 Force FiberTeleflex Medical · 2004
- 1 generation backK041216 Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc. · 2004
- This deviceK101377 Smith & Newphew Ultrabraid II SutureSmith & Newphew, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK132357 Smith & Nephew UltratapeSmith & Nephew, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132357Smith & Nephew UltratapeSmith & Nephew, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033654 | Force Fiber | Teleflex Medical | 2004 | — |
| −1 | K041216 | Smith & Nephew Ultrabraid Suture | Smith & Nephew, Inc. | 2004 | — |
| 0 (this device) | K101377 | Smith & Newphew Ultrabraid II Suture | Smith & Newphew, Inc. | 2011 | — |
| +1 | K132357 | Smith & Nephew Ultratape | Smith & Nephew, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 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 |
|---|---|---|---|
| * | K041216 | Smith & Nephew Ultrabraid SutureSummary page 1…11suture is substantially equivalent in Intended Use and fundamental scientific technology to the legally marketed Smith & Nephew ULTRABRAID suture cleared via K041 216. E. Description of Device The Smith & Nephew ULTRABRAID 11lis a non-absorbable, sterile, synthetic surgical suture… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132357 | Smith & Nephew Ultratape | 2013 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K132357 (Smith & Nephew, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K041216.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The Smith & Nephew ULTRABRAID TM 11Suture is indicated for use in
approximation and/or ligation of soft tissues, including allograft tissue for orthopedic
surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101377: Smith & Newphew Ultrabraid II Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101377
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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