510(k) · Cleared
ClearedMitek 2GII Meniscal Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Products · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Feb 15, 2001 as substantially equivalent to K970119 (Mitek Products, 1998) after a 192-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Feb 15, 2001
- Review
- 192 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970119 (1998). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK970119 Mitek Absorbable Polydioxanone (PDS) H FixMitek Products · 1998
- This deviceK002406 Mitek 2GII Meniscal Repair SystemMitek Products · 2001
- Descendant · cites it directly · 2 of its ownK023388 Mitek Rapidloc-PDS Meniscal Repair SystemMitek Worldwide · 2002
- Descendant · cites it directly · 0 of its ownK092836 Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2…Depuy Mitek, A Johnson & Johnson Company · 2010
- Descendant · 2 generations on · 0 of its ownK082518 Dual Needle Suture Passer SystemCayenne Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK053492 BioductBioduct, LLC · 2007
Most influential descendants
Showing 4 of 4 · See all- K023388Mitek Rapidloc-PDS Meniscal Repair SystemMitek Worldwide · 2002 · cites it directly2descendants
- K092836Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair…Depuy Mitek, A Johnson & Johnson Company · 2010 · cites it directly0descendants
- K082518Dual Needle Suture Passer SystemCayenne Medical, Inc. · 2009 · 2 generations on0descendants
- K053492BioductBioduct, LLC · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970119 | Mitek Absorbable Polydioxanone (PDS) H Fix | Mitek Products | 1998 | — |
| 0 (this device) | K002406 | Mitek 2GII Meniscal Repair System | Mitek Products | 2001 | — |
| +1 | K023388 | Mitek Rapidloc-PDS Meniscal Repair System | Mitek Worldwide | 2002 | — |
| +1 | K092836 | Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| +2 | K082518 | Dual Needle Suture Passer System | Cayenne Medical, Inc. | 2009 | — |
| +1 | K053492 | Bioduct | Bioduct, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K970119 | Mitek Absorbable Polydioxanone (PDS) H FixSummary page 1…e Classification: According to Section 513 of the Federal Food, Drug, and : Cosmetic Act, the device classification is Class IL Product Code: 87 MAI Predicate Devices: K970119 - Mitek “H” Fix; NDA#18-331 — PDS Absorbable Suture Product Description: The Mitek RapidLoc™ Meniscal Repair System described in… | 1998 |
| * | — | PDS Absorbable Suture Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).
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/K002406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002406: Mitek 2GII Meniscal Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002406
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026