510(k) · Cleared
ClearedSuperBall Meniscal Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arcuro Medical, Ltd. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jun 5, 2018 as substantially equivalent to K092508 (Smith & Nephew, Inc., 2010) after a 133-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Jun 5, 2018
- Review
- 133 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925573 (1993). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 2 generations backK002261 MR-IIISmith & Nephew, Inc. · 2000
- 1 generation backK092508 Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse…Smith & Nephew, Inc. · 2010 · Recalled
- This deviceK180191 SuperBall Meniscal Repair SystemArcuro Medical, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK223500 SuperBall Meniscal Repair SystemArcuro Medical, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK244015 SuperBall-RC™Arcuro Medical, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView 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 | K092508 | Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix… | Smith & Nephew, Inc. | 2010 | 3 |
| 0 (this device) | K180191 | SuperBall Meniscal Repair System | Arcuro Medical, Ltd. | 2018 | — |
| +1 | K223500 | SuperBall Meniscal Repair System | Arcuro Medical, Ltd. | 2023 | — |
| +2 | K244015 | SuperBall-RC™ | Arcuro Medical, Ltd. | 2025 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K092508 | Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…Summary page 4…cal suture Regulatory Class: II Product Code and Regulation Number: GAT; 21 CFR 878.5000 Predicate Device: Smith & Nephew, Inc.’s FAST-FIX 360 Meniscal Repair System (K092508) Reference Device: Genzyme Biosurgery COTTONY II, “silky” I I POLYDEKO & TEVDEKO II Polyester Nonabsorbable Su… | 2010 |
| † | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | 2002 |
| † | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223500 | SuperBall Meniscal Repair System | 2023 | 1 |
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 25 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K223500 (Arcuro Medical, Ltd., 2023) has gone furthest, with 1 descendant 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. 2018, 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 SuperBall Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair 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/K180191 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180191: SuperBall Meniscal Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180191
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