510(k) · Cleared

Cleared

KYPHON (R) HV-R (R) Bone Cement

K150460510(k) TraditionalCleared Apr 28, 201564-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

Medtronic Sofamor Danck USA, Inc. · NDN Cement, Bone, Vertebroplasty

Cleared on Apr 28, 2015 as substantially equivalent to K093828 (Medtronic, Inc., 2010) and 1 other predicate after a 64-day review. Its family tree reaches back 6 generations to 2001. 162 later devices descend from it.

Decided: Apr 28, 2015
Review: 64 days
Class: Class II
Product code: NDN
Recalls: None
Predicates: 2

Its longest line of descent runs back 6 generations to K002652 (2001). 8 ancestors in all. 162 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 6 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
5 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
4 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
3 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
2 generations backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
1 generation backK102397 Kyphon Xpede Bone CementMedtronic · 2011
This deviceK150460 KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015
Descendant · cites it directly · 159 of its ownK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
Descendant · 2 generations on · 106 of its ownK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
Descendant · 2 generations on · 91 of its ownK170347 CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017
Descendant · 2 generations on · 64 of its ownK171938 KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic · 2017
Descendant · cites it directly · 52 of its ownK160983 Kyphon HV-R Bone CementMedtronic, Inc. · 2016

Showing 5 of 162 descendants. See all descendants

Descendants cleared per year

2016high 27 (2026) · low 3 (2016)2026

Most influential descendants

Showing 5 of 162 · See all

K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016 · cites it directly159descendants
K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl · 2016 · 2 generations on106descendants
K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017 · 2 generations on91descendants
K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic · 2017 · 2 generations on64descendants
K160983Kyphon HV-R Bone CementMedtronic, Inc. · 2016 · cites it directly52descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K002652	Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii	Stryker Corp.	2001	1
−5	K033801	Kyphx HV-R, Model C01A	Kyphon, Inc.	2004	2
−4	K041584	Kyphx HV-R Bone Cement, Model C01A	Kyphon, Inc.	2004	2
−3	K042691	Vertefix Vertebroplasty Procedure Set	Cook, Inc.	2005	—
−2	K060300	Confidence High Viscosity Bone Cement	Disc-O-Tech Medical Technologies, Ltd.	2006	8
−1	K102397	Kyphon Xpede Bone Cement	Medtronic	2011	—
0 (this device)	K150460	KYPHON (R) HV-R (R) Bone Cement	Medtronic Sofamor Danck USA, Inc.	2015	—
+1	K152604	KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set	Medtronic Sofamor Danek USA, Incorporated	2016	—
+2	K160879	CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated…	Medos International Sàrl	2016	—
+2	K170347	CD HORIZON™ Fenestrated Screw Set	Medtronic Sofamor Danek USA	2017	—
+2	K171938	KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set	Medtronic	2017	—
+1	K160983	Kyphon HV-R Bone Cement	Medtronic, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	3	0
2017	5	0
2018	8	0
2019	7	0
2020	14	0
2021	15	0
2022	16	0
2023	25	0
2024	22	0
2025	20	0
2026	27	0

FIG. 1 — Lineage of K150460, 2001–2026Source: 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? (2)

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
*	K093828	Kyph X HV-R Bone Cement Summary page 4 …y of the Technological Characteristics: The subject KYPHON® HV-R® Bone Cement has the same fundamental scientific technology as the predicates KYPHON® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone K15046…	Medtronic, Inc.	2010	—
*	K102397	Kyphon Xpede Bone Cement Summary page 5 …=== K150460 Page 2 of 2 Cement (K102397 S.E. 2/28/2011). The subject device utilizes equivalent implant materials and sterilization methods. Identification of Legally…	Medtronic	2011	—

Also cleared against K093828: 2 other devices →

What descends from it? (162)

See all 162

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

Number	Device	Applicant	Decided	Descendants
K152604	KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set	Medtronic Sofamor Danek USA, Incorporated	2016	159
K160983	Kyphon HV-R Bone Cement	Medtronic, Inc.	2016	52

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 14 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
5 of the 8 ancestors have a recall of any class.
Of its descendants, K152604 (Medtronic Sofamor Danek USA, Incorporated, 2016) has gone furthest, with 159 descendants of its own.
2 other devices also cite its predicate K093828.

How does its category compare?

All NDN devices

NDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?

KYPHON® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150460 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150460: KYPHON (R) HV-R (R) 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/K150460

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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