510(k) · Cleared

Cleared

Crosstrees Pva Pod

K133372510(k) SpecialCleared Dec 6, 201335-day reviewClass II21 CFR 888.3027

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Crosstrees Medical, Inc. · NDN Cement, Bone, Vertebroplasty

Cleared on Dec 6, 2013 as substantially equivalent to K130089 (Crosstrees Medical, Inc., 2013) after a 35-day review. Its family tree reaches back 2 generations to 2012.

Decided: Dec 6, 2013
Review: 35 days
Class: Class II
Product code: NDN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K100404 (2012). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK100404 Ascendx VCF Reduction SystemAoi Medical, Inc. · 2012
1 generation backK130089 Crosstrees Pva PodCrosstrees Medical, Inc. · 2013
This deviceK133372 Crosstrees Pva PodCrosstrees Medical, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K100404	Ascendx VCF Reduction System	Aoi Medical, Inc.	2012	—
−1	K130089	Crosstrees Pva Pod	Crosstrees Medical, Inc.	2013	—
0 (this device)	K133372	Crosstrees Pva Pod	Crosstrees Medical, Inc.	2013	—

FIG. 1 — Lineage of K133372, 2012–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K130089	Crosstrees Pva Pod Summary page 1 …Delivery Device Classification Name 888.3027 - Cement, Bone, Vertebroplasty 888.1100 - Arthroscope Predicate Devices Crosstrees® PVA Pod Device (K 130089) Intended Use The Crosstrees® Pod device is intended to provide surgeons with a percutaneous means to deliver bone cement to pai…	Crosstrees Medical, Inc.	2013	—

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?

The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 8 months on median.
None of the 2 ancestors has a recall.

How does its category compare?

All NDN devices

NDN 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

2007high 11 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDN

90in 2024

2007high 215 (2010) · low 76 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NDN

4in 2013

2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NDN

626in 2025

2007high 626 (2025) · low 21 (2007)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® 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/K133372 · printed Nov 4, 2026

Cite this page

510(k) Report. “K133372: 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/K133372

Report an extraction error

Are you the manufacturer?

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