510(k) · Cleared
ClearedIvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivy Sports Medicine, LLC · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jul 14, 2016 as substantially equivalent to K121861 (Smith & Nephew, Inc., 2012) after a 262-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Jul 14, 2016
- Review
- 262 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050021 (2005). 11 ancestors in all, the oldest K925573 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK050021 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2005
- 3 generations backK070216 Vari-Lase Bright Tip FiberVascular Solutions, Inc. · 2007
- 2 generations backK072332 Vari-Lase Wire FiberVascular Solutions, Inc. · 2008 · Recalled
- 1 generation backK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012
- This deviceK153087 IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight…Ivy Sports Medicine, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050021 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2005 | — |
| −3 | K070216 | Vari-Lase Bright Tip Fiber | Vascular Solutions, Inc. | 2007 | — |
| −2 | K072332 | Vari-Lase Wire Fiber | Vascular Solutions, Inc. | 2008 | 1 |
| −1 | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra… | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K153087 | IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR… | Ivy Sports Medicine, LLC | 2016 | — |
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 |
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 |
|---|---|---|---|
| * | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Summary page 4…d Performance to the following legally marketed device in commercial distribution: Smith & Nephew FAST- FIX 360 Me niscal Repair System cleared under K121861. Page 6-1 of 3 510(k) Summary K153087… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 7 other devices also cite its predicate K121861.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 IvyAIR Meniscus System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The lvyAIR Meniscus System is indicated for use in meniscal repairs and allograft transplant procedures. The IvyAIR Meniscus System device is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153087 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153087: IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153087
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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