510(k) · Cleared
ClearedCrosstrees Pva Pod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crosstrees Medical, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Aug 9, 2013 as substantially equivalent to K100404 (Aoi Medical, Inc., 2012) after a 207-day review. Its family tree reaches back 1 generation to 2012. 1 later device descends from it.
- Decided
- Aug 9, 2013
- Review
- 207 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100404 (2012). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K133372Crosstrees Pva PodCrosstrees Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100404 | Ascendx VCF Reduction System | Aoi Medical, Inc. | 2012 | — |
| 0 (this device) | K130089 | Crosstrees Pva Pod | Crosstrees Medical, Inc. | 2013 | — |
| +1 | K133372 | Crosstrees Pva Pod | Crosstrees Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 NDN? 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 NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K100404 | Ascendx VCF Reduction SystemSummary page 2…0(312/; Substantial Equivalence The Crosstrees® PVA Pod device is substantially equivalent to the predicate devices, Ascendx Spine, Inc.'s Ascendx VCF Repair System (K100404). The Crosstrees® PVA Pod device has the same intended uses and similar indications, technological characteristics, and principle… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133372 | Crosstrees Pva Pod | 2013 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K133372 (Crosstrees Medical, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, 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 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Crosstrees® PVA Pod device is intended to provide surgeons with a percutaneous means to deliver bone cement to painful pathologic compression fractures of the vertebral body in levels T4-L5 of the thoracic and lumbar spine. Pathologic fractures of the vertebral body may be caused by osteoporosis. It is intended to be used in combination with Crosstrees Fortibrae Bone Cement when delivered by the Crosstrees CDrive Bone Filler Delivery System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130089: Crosstrees Pva Pod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130089
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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