510(k) · Cleared
ClearedStryker Mini-Mender Meniscal Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Dec 2, 2003 as substantially equivalent to K021019 (Genzyme Corp., 2002) after a 76-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Dec 2, 2003
- Review
- 76 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930738 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 1 generation backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
- This deviceK032901 Stryker Mini-Mender Meniscal Repair SystemStryker Endoscopy · 2003
- Descendant · cites it directly · 0 of its ownK082535 Covidien Sports Surgery as Meniscal Repair DeviceSurgical Devices, A Global Business Unit Covidien · 2008
Most influential descendants
Showing 1 of 1 · See all- K082535Covidien Sports Surgery as Meniscal Repair DeviceSurgical Devices, A Global Business Unit Covidien · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | 9 |
| −1 | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | Genzyme Corp. | 2002 | 7 |
| 0 (this device) | K032901 | Stryker Mini-Mender Meniscal Repair System | Stryker Endoscopy | 2003 | — |
| +1 | K082535 | Covidien Sports Surgery as Meniscal Repair Device | Surgical Devices, A Global Business Unit Covidien | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture Our reading of the summary gave “K021019” beside “510(k)”; FDA’s K021019 is the only number that fits it and carries the summary’s name for the device. Summary page 2…== Page 2 === Stryker will acquire suture from a suture manufacturer that has received FDA clearance for the suture, such as Genzyme Biosurgery/Teleflex Medical (510(k) #K021019), with an intended use as specified for the Mini-Mender Meniscal Repair System. Stryker will assemble the suture to the Introduce… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082535 | Covidien Sports Surgery as Meniscal Repair Device | 2008 | 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 9 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K082535 (Surgical Devices, A Global Business Unit Covidien, 2008) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K021019.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Stryker Mini-Mender Meniscal Repair System is intended for use in arthroscopic suture fixation techniques of meniscal tears.
The Stryker Mini-Mender Meniscal Repair System is intended for single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032901: Stryker Mini-Mender 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/K032901
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