510(k) · Cleared

Cleared

Stryker Vertaplex Radiopaque Bone Cement

K072118510(k) TraditionalCleared Dec 7, 2007128-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

Stryker Corp. · NDN Cement, Bone, Vertebroplasty

Cleared on Dec 7, 2007 as substantially equivalent to K032945 (Stryker Corp., 2004) after a 128-day review. Its family tree reaches back 1 generation to 2004. 63 later devices descend from it.

Decided: Dec 7, 2007
Review: 128 days
Class: Class II
Product code: NDN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032945 (2004). 63 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK032945 Simplex XStryker Corp. · 2004 · Recalled
This deviceK072118 Stryker Vertaplex Radiopaque Bone CementStryker Corp. · 2007
Descendant · cites it directly · 59 of its ownK091606 Vertaplex HV (Single Pack and Dual Pack)Stryker Corp. · 2009
Descendant · 2 generations on · 53 of its ownK150582 Vertaplex® High Viscosity (HV) Radiopaque Bone CementStryker Corporation · 2015 · Recalled
Descendant · 3 generations on · 52 of its ownK163032 Kyphon Xpede Bone CementMedtronic, Inc. · 2017
Descendant · 4 generations on · 51 of its ownK180700 KYPHON HV-R Bone CementMedtronic Sofamor Danek USA, Inc. · 2018
Descendant · 4 generations on · 50 of its ownK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019

Showing 5 of 63 descendants. See all descendants

Descendants cleared per year

2009high 17 (2026) · low 0 (2010)2026

Most influential descendants

Showing 5 of 63 · See all

K091606Vertaplex HV (Single Pack and Dual Pack)Stryker Corp. · 2009 · cites it directly59descendants
K150582Vertaplex® High Viscosity (HV) Radiopaque Bone CementStryker Corporation · 2015 · 2 generations on53descendants
K163032Kyphon Xpede Bone CementMedtronic, Inc. · 2017 · 3 generations on52descendants
K180700KYPHON HV-R Bone CementMedtronic Sofamor Danek USA, Inc. · 2018 · 4 generations on51descendants
K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2019 · 4 generations on50descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032945	Simplex X	Stryker Corp.	2004	2
0 (this device)	K072118	Stryker Vertaplex Radiopaque Bone Cement	Stryker Corp.	2007	—
+1	K091606	Vertaplex HV (Single Pack and Dual Pack)	Stryker Corp.	2009	—
+2	K150582	Vertaplex® High Viscosity (HV) Radiopaque Bone Cement	Stryker Corporation	2015	1
+3	K163032	Kyphon Xpede Bone Cement	Medtronic, Inc.	2017	—
+4	K180700	KYPHON HV-R Bone Cement	Medtronic Sofamor Danek USA, Inc.	2018	—
+4	K191148	Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…	Medtronic Sofamor Danek USA, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2015	1	0
2017	2	0
2018	3	0
2019	1	0
2020	2	0
2021	5	0
2022	6	0
2023	7	0
2024	9	0
2025	9	0
2026	17	0

FIG. 1 — Lineage of K072118, 2004–2026Source: 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

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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
*	K032945	Simplex X Summary page 1 …PMMA) bone cement 21 CFR§ 888.3027, LOD, NON Predicate Devices: Stryker Spineplex Radiopaque Bone Cement - K032945 Description: Vertaplex is Polymethyl Methacrylate cement used for the treatment of painful…	Stryker Corp.	2004	2

Also cleared against K032945: 14 other devices →

What descends from it? (63)

See all 63

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K091606	Vertaplex HV (Single Pack and Dual Pack)	Stryker Corp.	2009	59
K211238	SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…	Stryker Instruments	2021	2

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 a recall.
Of its descendants, K091606 (Stryker Corp., 2009) has gone furthest, with 59 descendants of its own.
14 other devices also cite its predicate K032945.

How does its category compare?

All NDN devices

NDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

Vertaplex Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty of kyphoplasty procedures.

Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072118 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072118: Stryker Vertaplex Radiopaque Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072118

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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