510(k) · Cleared
ClearedSmith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N
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 Oct 18, 2012 as substantially equivalent to K041216 (Smith & Nephew, Inc., 2004) and 2 other predicates after a 114-day review. Its family tree reaches back 3 generations to 2005. 12 later devices descend from it.
- Decided
- Oct 18, 2012
- Review
- 114 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K050021 (2005). 10 ancestors in all, the oldest K925573 (1993). 12 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK050021 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2005
- 2 generations backK070216 Vari-Lase Bright Tip FiberVascular Solutions, Inc. · 2007
- 1 generation backK072332 Vari-Lase Wire FiberVascular Solutions, Inc. · 2008 · Recalled
- This deviceK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK203393 Fast-Fix FlexSmith & Nephew, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK153667 TRUESPAN Meniscal Repair SystemMedos International SARL · 2016
- Descendant · cites it directly · 1 of its ownK151105 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor…Smith & Nephew, Inc. · 2015 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · cites it directly2descendants
- K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 2 generations on1descendant
- K203393Fast-Fix FlexSmith & Nephew, Inc. · 2021 · cites it directly1descendant
- K153667TRUESPAN Meniscal Repair SystemMedos International SARL · 2016 · cites it directly1descendant
- K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc. · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050021 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2005 | — |
| −2 | K070216 | Vari-Lase Bright Tip Fiber | Vascular Solutions, Inc. | 2007 | — |
| −1 | K072332 | Vari-Lase Wire Fiber | Vascular Solutions, Inc. | 2008 | 1 |
| 0 (this device) | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra… | Smith & Nephew, Inc. | 2012 | — |
| +1 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2019 | — |
| +2 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2022 | — |
| +1 | K203393 | Fast-Fix Flex | Smith & Nephew, Inc. | 2021 | — |
| +1 | K153667 | TRUESPAN Meniscal Repair System | Medos International SARL | 2016 | — |
| +1 | K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and… | Smith & Nephew, Inc. | 2015 | 40 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (3)
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…air Systems are substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: K041216 LILTRABRAID Suture (cleared June 7, 2004) K072332 ULTRA FAST-FIX / ULTRA FAST-FIX AS Men/scat Repair System… | 2004 |
| * | K072332 | Vari-Lase Wire FiberSummary page 1…Scientific Technology to the following legally marketed devices in commercial distribution: K041216 LILTRABRAID Suture (cleared June 7, 2004) K072332 ULTRA FAST-FIX / ULTRA FAST-FIX AS Men/scat Repair Systems (cleared September 18, 2007) K092508 FAST-FIX 36… | 2008 |
| * | K092508 | Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…Summary page 1…Suture (cleared June 7, 2004) K072332 ULTRA FAST-FIX / ULTRA FAST-FIX AS Men/scat Repair Systems (cleared September 18, 2007) K092508 FAST-FIX 360 Meniscal Repair System (cleared January 28, 2010) The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-… | 2010 |
What descends from it? (12)
See all 128 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch… | 2019 | 2 |
| K203393 | Fast-Fix Flex | 2021 | 1 |
| K153667 | TRUESPAN Meniscal Repair System | 2016 | 1 |
| K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew… | 2015 | 1 |
| K233601 | Fixone Meniscal Repair | 2024 | 0 |
| K230891 | SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant | 2023 | 0 |
| K223122 | Menix®; Menix® Duo | 2023 | 0 |
| K153087 | IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus… | 2016 | 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 2 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K190125 (T.A.G. Medical Products Corporation, Ltd., 2019) has gone furthest, with 2 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. 2012, 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 ULTRA FAST-FIX Meniscal Repair System is intended for use as suture retention devices to facilitate percutaneous or 6ndloscopic soft tissue procedures. The ULTRA FAST-FIX System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. The ULTRA FAST-FIX AB Meniscal Repair System is intended for…
Read the full statement (179 words)
The ULTRA FAST-FIX Meniscal Repair System is intended for use as suture retention devices to facilitate percutaneous or 6ndloscopic soft tissue procedures. The ULTRA FAST-FIX System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
The ULTRA FAST-FIX AB Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endloscopic soft tissue procedures. The ULTRA FAST-FIX AB System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX AB System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
The FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endloscopic soft tissue procedures. The FAST-FIX 360 System is indicated for use in meniscal repairs and allograft transplant procedures. The FAST-FIX 360 System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121861
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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