510(k) · Cleared
Recalled · 2010Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB Meniscal Repair System, Straight,
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 Jan 28, 2010 as substantially equivalent to K002261 (Smith & Nephew, Inc., 2000) after a 164-day review. Its family tree reaches back 2 generations to 1993. 17 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 28, 2010
- Review
- 164 days
- Class
- Class II
- Product code
- GAT
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925573 (1993). 3 ancestors in all. 17 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 1 generation backK002261 MR-IIISmith & Nephew, Inc. · 2000
- This deviceK092508 Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse…Smith & Nephew, Inc. · 2010
- Descendant · cites it directly · 12 of its ownK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK180191 SuperBall Meniscal Repair SystemArcuro Medical, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK223500 SuperBall Meniscal Repair SystemArcuro Medical, Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Smith & Nephew, Inc. · 2012 · cites it directly12descendants
- K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · 2 generations on2descendants
- K180191SuperBall Meniscal Repair SystemArcuro Medical, Ltd. · 2018 · cites it directly2descendants
- K223500SuperBall Meniscal Repair SystemArcuro Medical, Ltd. · 2023 · 2 generations on1descendant
- K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| −1 | K002261 | MR-III | Smith & Nephew, Inc. | 2000 | — |
| 0 (this device) | K092508 | Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix… | Smith & Nephew, Inc. | 2010 | — |
| +1 | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra… | Smith & Nephew, Inc. | 2012 | — |
| +2 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2019 | — |
| +1 | K180191 | SuperBall Meniscal Repair System | Arcuro Medical, Ltd. | 2018 | — |
| +2 | K223500 | SuperBall Meniscal Repair System | Arcuro Medical, Ltd. | 2023 | — |
| +3 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002261 | MR-IIISummary page 1…nded Pse and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew FAST-FIX Meniscal Repair System (K002261) and Ethicon PDS Suture (N1833 1) E. Description of Device The Smith & Nephew FAST-FIX 360 Meniscal Repair System is an all-… | 2000 |
| Kept off the family tree | K018331 | Ethicon PDS Suture Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (17)
See all 174 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2010 | Not classified | Z-0419-2011 | Device Design | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. |
| Oct 14, 2010 | Not classified | Z-0421-2011 | Device Design | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. |
| Oct 14, 2010 | Not classified | Z-0420-2011 | Device Design | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K121861 (Smith & Nephew, Inc., 2012) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K002261.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092508: Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB Meniscal Repair System, Straight,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092508
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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