510(k) · Cleared
ClearedArthrex Meniscal Dart System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Aug 13, 1999 after a 304-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Aug 13, 1999
- Review
- 304 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK983577 Arthrex Meniscal Dart SystemArthrex, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK082999 Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral…Arthrex, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK070178 Aesculap Resorbable Pin, Model FR735Aesculap Implant System, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK053492 BioductBioduct, LLC · 2007
- Descendant · cites it directly · 0 of its ownK041128 Suture ArrowLinvatec Corp. · 2004
Most influential descendants
Showing 4 of 4 · See all- K082999Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral DartArthrex, Inc. · 2008 · cites it directly0descendants
- K070178Aesculap Resorbable Pin, Model FR735Aesculap Implant System, Inc. · 2007 · cites it directly0descendants
- K053492BioductBioduct, LLC · 2007 · cites it directly0descendants
- K041128Suture ArrowLinvatec Corp. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983577 | Arthrex Meniscal Dart System | Arthrex, Inc. | 1999 | — |
| +1 | K082999 | Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral Dart | Arthrex, Inc. | 2008 | — |
| +1 | K070178 | Aesculap Resorbable Pin, Model FR735 | Aesculap Implant System, Inc. | 2007 | — |
| +1 | K053492 | Bioduct | Bioduct, LLC | 2007 | — |
| +1 | K041128 | Suture Arrow | Linvatec Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 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 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 |
|---|---|---|---|
| * | — | Bionx Arrow Named without a submission number | |
| * | — | Clearfix Named without a submission number |
What descends from it? (4)
4 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, K082999 (Arthrex, Inc., 2008) has gone furthest, with 0 descendants of its own.
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 Arthrex Meniscal Dart System is intended for the repair of meniscal tears that would otherwise be considered for standard repair using suture
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/K983577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983577: Arthrex Meniscal Dart System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983577
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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