510(k) · Cleared
Recalled · Class II · 2015TFCC Fast-Fix Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Dec 5, 2013 as substantially equivalent to K092508 (Smith & Nephew, Inc., 2010) and 1 other predicate after a 153-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 5, 2013
- Review
- 153 days
- Class
- Class II
- Product code
- GAT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K925573 (1993). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 3 generations backK002261 MR-IIISmith & Nephew, Inc. · 2000
- 2 generations backK020480 RBMSmith & Nephew, Inc. · 2002 · Recalled
- 1 generation backK072322 Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007
- This deviceK132079 TFCC Fast-Fix KitSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK262357 Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| −3 | K002261 | MR-III | Smith & Nephew, Inc. | 2000 | — |
| −2 | K020480 | RBM | Smith & Nephew, Inc. | 2002 | 1 |
| −1 | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | Smith & Nephew, Inc. | 2007 | — |
| 0 (this device) | K132079 | TFCC Fast-Fix Kit | Smith & Nephew, Inc. | 2013 | — |
| +1 | K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K092508 | Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…Summary page 1…it is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: K092508 FAST-FIX 360 Meniscal Repair System (Cleared January 28, 2012)… | 2010 |
| * | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSummary page 1…tion: K092508 FAST-FIX 360 Meniscal Repair System (Cleared January 28, 2012) K072322 ULTRA FAST-FIX and ULTRA FAST-FIX AB Meniscal Repair Systems (Cle… | 2007 |
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 |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2015 | Class II | Z-1822-2015 | Package design/selection | Sterility of device maybe compromised |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K262357 (Arthrex, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K092508.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 TFCC FAST-FIX Kit is Intended for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132079: TFCC Fast-Fix Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132079
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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