510(k) · Cleared
ClearedCovidien Sports Surgery as Meniscal Repair Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Devices, A Global Business Unit Covidien · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Dec 1, 2008 as substantially equivalent to K930591 (Davis & Geck, Inc., 1993) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Dec 1, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K925573 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 3 generations backK002261 MR-IIISmith & Nephew, Inc. · 2000
- 2 generations backK020480 RBMSmith & Nephew, Inc. · 2002 · Recalled
- 1 generation backK072322 Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007
- This deviceK082535 Covidien Sports Surgery as Meniscal Repair DeviceSurgical Devices, A Global Business Unit Covidien · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| −3 | K002261 | MR-III | Smith & Nephew, Inc. | 2000 | — |
| −2 | K020480 | RBM | Smith & Nephew, Inc. | 2002 | 1 |
| −1 | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | Smith & Nephew, Inc. | 2007 | — |
| 0 (this device) | K082535 | Covidien Sports Surgery as Meniscal Repair Device | Surgical Devices, A Global Business Unit Covidien | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K930591 | TI-Cron and Dacron SuturesSummary page 1…Devices, a global business unit of Tyco Healthcare Group LP (dibla Covidien) 510(k): K930591 Classification Name: Suture Retention Device/Synthetic Nonabsorbable… | 1993 |
| * | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSummary page 1…System 510(k) Submitter/Hiolder Smith & Nephew, Inc. Endoscopy Div. 510(k) no.: K072322 Classification Name: Nonabsorbable poly(ethylene terephthalate) surgical… | 2007 |
| * | K032901 | Stryker Mini-Mender Meniscal Repair SystemSummary page 1…Stryker Mini-Mender Meniscal Repair System 5 10(k) Submitter/H1older Stryker Endoscopy 510(k) no.: K032901 DEVICE DESCRIPTION: The Covidien Sports Surgery AS Meniscal Repair Device is a… | 2003 |
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 15 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 5 of the 9 ancestors have a recall of any class.
- 4 other devices also cite its predicate K930591.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Covidien Sports Surgery AS Meniscal Repair Device is Intended for use for approximation of soft tissue such as the repair of meniscal tear Injuries
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082535: Covidien Sports Surgery as Meniscal Repair Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082535
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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