510(k) · Cleared
ClearedUltra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems
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 Sep 18, 2007 as substantially equivalent to K002261 (Smith & Nephew, Inc., 2000) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1993. 15 later devices descend from it.
- Decided
- Sep 18, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925573 (1993). 4 ancestors in all. 15 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 2 generations backK002261 MR-IIISmith & Nephew, Inc. · 2000
- 1 generation backK020480 RBMSmith & Nephew, Inc. · 2002 · Recalled
- This deviceK072322 Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK073149 Meniscal CinchArthrex, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK132043 Arthrex SpeedcinchArthrex, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK190707 Arthrex SoftStitchArthrex, Inc. · 2020
- Descendant · 3 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 · 4 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 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K073149Meniscal CinchArthrex, Inc. · 2008 · cites it directly9descendants
- K132043Arthrex SpeedcinchArthrex, Inc. · 2013 · 2 generations on6descendants
- K190707Arthrex SoftStitchArthrex, Inc. · 2020 · 2 generations on2descendants
- K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · 3 generations on2descendants
- K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| −2 | K002261 | MR-III | Smith & Nephew, Inc. | 2000 | — |
| −1 | K020480 | RBM | Smith & Nephew, Inc. | 2002 | 1 |
| 0 (this device) | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | Smith & Nephew, Inc. | 2007 | — |
| +1 | K073149 | Meniscal Cinch | Arthrex, Inc. | 2008 | — |
| +2 | K132043 | Arthrex Speedcinch | Arthrex, Inc. | 2013 | — |
| +2 | K190707 | Arthrex SoftStitch | Arthrex, Inc. | 2020 | — |
| +3 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2019 | — |
| +4 | 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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2025 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K002261 | MR-IIISummary page 1…lly equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Smith & Nephew FAST-FIX (K002261) and FAST-FIX AB (K020480) Meniscal Repairs Systems. Page 1 of 2… | 2000 |
| * | K020480 | RBMSummary page 1…Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Smith & Nephew FAST-FIX (K002261) and FAST-FIX AB (K020480) Meniscal Repairs Systems. Page 1 of 2 Smith &Nephew,… | 2002 |
What descends from it? (15)
See all 156 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 14 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K073149 (Arthrex, Inc., 2008) has gone furthest, with 9 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. 2007, 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 ULTRA FAST-FIX Meniscal Repair Systems and ULTRA FAST-FIX AB Meniscal Repair Systems are intended for use as suture retention devices 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/K072322 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072322: Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072322
Report an extraction error
Are you the manufacturer?
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