510(k) · Cleared
ClearedArthrex Aspirate Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · FMF Syringe, Piston
Cleared on Sep 29, 2006 as substantially equivalent to K041991 (Isotis Orthobiologics, Inc., 2004) and 2 other predicates after a 46-day review. Its family tree reaches back 2 generations to 2001. 37 later devices descend from it.
- Decided
- Sep 29, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K003286 (2001). 7 ancestors in all. 37 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003286 Symphony Graft Delivery SystemDepuyacromed · 2001
- 1 generation backK012738 Symphony Graft Delivery System (GDS)Depuyacromed · 2001
- This deviceK062365 Arthrex Aspirate KitArthrex, Inc. · 2006
- Descendant · cites it directly · 36 of its ownK121124 Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012
- Descendant · 2 generations on · 32 of its ownK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- Descendant · 2 generations on · 31 of its ownK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- Descendant · 3 generations on · 21 of its ownK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- Descendant · 4 generations on · 11 of its ownK170675 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K121124Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012 · cites it directly36descendants
- K133021Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014 · 2 generations on32descendants
- K141245Etex Mixing and Delivery SystemEtex Corporation · 2014 · 2 generations on31descendants
- K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016 · 3 generations on21descendants
- K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003286 | Symphony Graft Delivery System | Depuyacromed | 2001 | — |
| −1 | K012738 | Symphony Graft Delivery System (GDS) | Depuyacromed | 2001 | — |
| 0 (this device) | K062365 | Arthrex Aspirate Kit | Arthrex, Inc. | 2006 | — |
| +1 | K121124 | Arthrex Mixing and Delivery System | Arthrex, Inc. | 2012 | — |
| +2 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| +2 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| +3 | K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016 | — |
| +4 | K170675 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K041991 | Aspirex - Bone Marrow Aspirate KitSummary page 1…Piston Syringe DEVICE PRODUCT CODE/CLASSIFICATION: FMF: Class II 21 CFR 880.5860 PREDICATE DEVICES K041991: AspirexTM Bone Marrow Aspirate Kit, IsoTis OrthoBiologics K022246: Symphony Graft Delivery System, DePuy Acromed K012738: Sympho… | 2004 |
| * | K022246 | Modification to Symphony Graft Delivery SystemSummary page 1…FMF: Class II 21 CFR 880.5860 PREDICATE DEVICES K041991: AspirexTM Bone Marrow Aspirate Kit, IsoTis OrthoBiologics K022246: Symphony Graft Delivery System, DePuy Acromed K012738: Symphony Graft Delivery System, DePuy Acromed DEVICE DESCRIPTION AND INT… | 2002 |
| * | K012738 | Symphony Graft Delivery System (GDS)Summary page 1…21 CFR 880.5860 PREDICATE DEVICES K041991: AspirexTM Bone Marrow Aspirate Kit, IsoTis OrthoBiologics K022246: Symphony Graft Delivery System, DePuy Acromed K012738: Symphony Graft Delivery System, DePuy Acromed DEVICE DESCRIPTION AND INTENDED USE The Arthrex Aspirate Kit contains piston syri… | 2001 |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121124 | Arthrex Mixing and Delivery System | 2012 | 36 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K121124 (Arthrex, Inc., 2012) has gone furthest, with 36 descendants of its own.
- 2 other devices also cite its predicate K041991.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Arthrex Aspirate Kit is intended for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without pre-filling with a bone void filler (allograft, autograft or synthetic bone graft material).
The kit is designed to facilitate the pre-mixing of autologous blood, bone marrow, I.V. fluids, platelet-rich plasma, or plasma with bone void filler and the delivery to an orthopedic surgical site, as deemed necessary by the clinical use requirements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062365: Arthrex Aspirate Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062365
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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