510(k) · Cleared
ClearedEquestra Fluid Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · HRX Arthroscope
Cleared on Jul 23, 2004 after a 149-day review. The FDA summary names its predicate without a number. 1 of the 53 devices in its family, counting itself, has a Class I recall. 52 later devices descend from it.
- Decided
- Jul 23, 2004
- Review
- 149 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 6 citing it directly. 1 of the 53 devices in this family, counting this one, has a Class I recall.
- This deviceK040483 Equestra Fluid Delivery SystemMedtronic Sofamor Danek, Inc. · 2004
- Descendant · cites it directly · 29 of its ownK043602 Quadrant Retractor SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 18 of its ownK060148 Ebi Vertebroplasty SystemsEbi, L.P. · 2006
- Descendant · cites it directly · 17 of its ownK063248 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- Descendant · 3 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K060973 Vycor Surgical Access Systems2 generations on · 2006
Most influential descendants
Showing 5 of 52 · See all- K043602Quadrant Retractor SystemMedtronic Sofamor Danek · 2005 · cites it directly29descendants
- K060148Ebi Vertebroplasty SystemsEbi, L.P. · 2006 · cites it directly18descendants
- K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007 · cites it directly17descendants
- K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 2 generations on14descendants
- K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040483 | Equestra Fluid Delivery System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| +1 | K043602 | Quadrant Retractor System | Medtronic Sofamor Danek | 2005 | — |
| +1 | K060148 | Ebi Vertebroplasty Systems | Ebi, L.P. | 2006 | — |
| +1 | K063248 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| +3 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 1 |
| 2007 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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.
1 device in this family has a Class I recall. 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 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? (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 |
|---|---|---|---|
| * | — | bone tamps Named without a submission number | |
| * | — | cannulas Named without a submission number | |
| * | — | stylets Named without a submission number |
What descends from it? (52)
See all 526 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060973Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K043602 (Medtronic Sofamor Danek, 2005) has gone furthest, with 29 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The EQUESTRATM Delivery System is intended to provide surgeons with a percutaneous means of delivering legally cleared bone cement to the surgical site in orthopedic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040483 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040483: Equestra Fluid Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040483
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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