510(k) · Cleared
ClearedArthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral Dart
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 Dec 30, 2008 as substantially equivalent to K983577 (Arthrex, Inc., 1999) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Dec 30, 2008
- Review
- 83 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983577 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK983577 Arthrex Meniscal Dart SystemArthrex, Inc. · 1999
- This deviceK082999 Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral…Arthrex, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983577 | Arthrex Meniscal Dart System | Arthrex, Inc. | 1999 | — |
| 0 (this device) | K082999 | Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral Dart | Arthrex, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K983577 | Arthrex Meniscal Dart SystemSummary page 1…HTY-Pin, fixation, smooth Classification Name MAI-Fastener, Fixation, Biodegradable, Soft Tissue Predicate Devices K983577, Arthrex Meniscal Dart System K991971, Arthrex Chrondral Dart Device Description The… | 1999 |
| * | K991971 | Arthrex Chondral Dart, Model AR-4005B-18Summary page 1…MAI-Fastener, Fixation, Biodegradable, Soft Tissue Predicate Devices K983577, Arthrex Meniscal Dart System K991971, Arthrex Chrondral Dart Device Description The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex an… | 2000 |
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K983577.
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. 2008, this device’s year, is highlighted.
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.
The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpa/metatarsal), osteochondral fragments (talus vault, femoral chondyle) and cancellous fragments (talus).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082999 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082999: Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral Dart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082999
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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