510(k) · Cleared
ClearedMitek Absorbable Polydioxanone (PDS) H Fix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Products · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 30, 1998 after a 381-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jan 30, 1998
- Review
- 381 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK970119 Mitek Absorbable Polydioxanone (PDS) H FixMitek Products · 1998
- Descendant · cites it directly · 4 of its ownK002406 Mitek 2GII Meniscal Repair SystemMitek Products · 2001
- Descendant · cites it directly · 2 of its ownK023388 Mitek Rapidloc-PDS Meniscal Repair SystemMitek Worldwide · 2002
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK053492 BioductBioduct, LLC · 2007
Most influential descendants
Showing 5 of 5 · See all- K002406Mitek 2GII Meniscal Repair SystemMitek Products · 2001 · cites it directly4descendants
- 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 · 2 generations on0descendants
- K082518Dual Needle Suture Passer SystemCayenne Medical, Inc. · 2009 · 2 generations on0descendants
- K053492BioductBioduct, LLC · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970119 | Mitek Absorbable Polydioxanone (PDS) H Fix | Mitek Products | 1998 | — |
| +1 | K002406 | Mitek 2GII Meniscal Repair System | Mitek Products | 2001 | — |
| +1 | K023388 | Mitek Rapidloc-PDS Meniscal Repair System | Mitek Worldwide | 2002 | — |
| +2 | 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 | — |
| +2 | K053492 | Bioduct | Bioduct, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | — | Acufex “T” Fix Device Named without a submission number | |
| * | — | PDS II Suture Named without a submission number |
What descends from it? (5)
2 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?
- Of its descendants, K002406 (Mitek Products, 2001) has gone furthest, with 4 descendants of its own.
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.
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?
Mitek meniscal fasteners "H" Fix PDS are intended for use in the repair or torn meniscal tissue in the red/red zone of the meniscus (outer 1/3 ) as well as the repair of a separation of the meniscus from the synovium
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/K970119 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970119: Mitek Absorbable Polydioxanone (PDS) H Fix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970119
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