510(k) · Cleared
ClearedOmnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair System/12 Degree, Model 228141
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 4, 2010 as substantially equivalent to K002406 (Mitek Products, 2001) and 1 other predicate after a 142-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Feb 4, 2010
- Review
- 142 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970119 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK970119 Mitek Absorbable Polydioxanone (PDS) H FixMitek Products · 1998
- 2 generations backK002406 Mitek 2GII Meniscal Repair SystemMitek Products · 2001
- 1 generation backK023388 Mitek Rapidloc-PDS Meniscal Repair SystemMitek Worldwide · 2002
- This deviceK092836 Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2…Depuy Mitek, A Johnson & Johnson Company · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970119 | Mitek Absorbable Polydioxanone (PDS) H Fix | Mitek Products | 1998 | — |
| −2 | K002406 | Mitek 2GII Meniscal Repair System | Mitek Products | 2001 | — |
| −1 | K023388 | Mitek Rapidloc-PDS Meniscal Repair System | Mitek Worldwide | 2002 | — |
| 0 (this device) | K092836 | Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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 |
|---|---|---|---|
| * | K002406 | Mitek 2GII Meniscal Repair SystemSummary page 2…The proposed OMNIS PAN Meniscal Repair System is substantial ly equivalent to: * K002406 Mitek FRapidloc Meniscal Repair Device (February 15, 2001);… | 2001 |
| * | K023388 | Mitek Rapidloc-PDS Meniscal Repair SystemSummary page 2…* K002406 Mitek FRapidloc Meniscal Repair Device (February 15, 2001); * K023388 Mitek PDS Rapidloc Meniscal Repair Device (December 27, 2002).… | 2002 |
| † | K071257 | Mini Quickanchor and Quickanchor Plus with Orthocord | 2007 |
| † | K080918 | Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet… | 2008 |
| † | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | 2007 |
| † | K073149 | Meniscal Cinch | 2008 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K002406.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The proposed OMNISPAN Meniscal Repair System is intended for use in the arthroscopic fixation of soft tissue procedures such as meniscal repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092836 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092836: Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair System/12 Degree, Model 228141.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092836
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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