510(k) · Cleared

Recalled · 2009

Kyphx HV-R, Model C01A

K033801510(k) TraditionalCleared Apr 1, 2004115-day reviewClass II21 CFR 888.3027Recalls 2

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

Kyphon, Inc. · NDN Cement, Bone, Vertebroplasty

Cleared on Apr 1, 2004 as substantially equivalent to K002652 (Stryker Corp., 2001) after a 115-day review. Its family tree reaches back 1 generation to 2001. 212 later devices descend from it. It has been recalled 2 times.

Decided: Apr 1, 2004
Review: 115 days
Class: Class II
Product code: NDN
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K002652 (2001). 212 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
This deviceK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004
Descendant · cites it directly · 209 of its ownK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
Descendant · 2 generations on · 189 of its ownK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
Descendant · 2 generations on · 176 of its ownK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
Descendant · cites it directly · 167 of its ownK093828 Kyph X HV-R Bone CementMedtronic, Inc. · 2010
Descendant · cites it directly · 165 of its ownK102397 Kyphon Xpede Bone CementMedtronic · 2011

Showing 5 of 212 descendants. See all descendants

Descendants cleared per year

2004high 28 (2026) · low 1 (2004)2026

Most influential descendants

Showing 5 of 212 · See all

K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · cites it directly209descendants
K042691Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005 · 2 generations on189descendants
K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · 2 generations on176descendants
K093828Kyph X HV-R Bone CementMedtronic, Inc. · 2010 · cites it directly167descendants
K102397Kyphon Xpede Bone CementMedtronic · 2011 · cites it directly165descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002652	Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii	Stryker Corp.	2001	1
0 (this device)	K033801	Kyphx HV-R, Model C01A	Kyphon, Inc.	2004	—
+1	K041584	Kyphx HV-R Bone Cement, Model C01A	Kyphon, Inc.	2004	2
+2	K042691	Vertefix Vertebroplasty Procedure Set	Cook, Inc.	2005	—
+2	K060300	Confidence High Viscosity Bone Cement	Disc-O-Tech Medical Technologies, Ltd.	2006	8
+1	K093828	Kyph X HV-R Bone Cement	Medtronic, Inc.	2010	—
+1	K102397	Kyphon Xpede Bone Cement	Medtronic	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	4	0
2006	7	0
2007	10	0
2008	1	0
2009	2	0
2010	2	0
2011	5	0
2012	1	0
2013	2	0
2014	2	0
2015	2	0
2016	3	0
2017	7	0
2018	9	0
2019	8	0
2020	16	0
2021	15	0
2022	16	0
2023	26	0
2024	24	0
2025	21	0
2026	28	0

FIG. 1 — Lineage of K033801, 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K002652	Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii Summary page 1 …1350 Bordeaux Drive Sunnyv'ale, CA 94089 Telephone: 408-548-6500 Predicate Device(s): K002652: Stryker Hown-edica Surgical Simplex P Radiopaque pre-packed in ACM aind MixEvac II.…	Stryker Corp.	2001	1
Kept off the family tree	K0017004	Howmedica Osteonics Surgical Simplex P Radiopaque Bone Cement Number could not be read

Also cleared against K002652: 3 other devices →

What descends from it? (212)

See all 212

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

Number	Device	Applicant	Decided	Descendants
K041584	Kyphx HV-R Bone Cement, Model C01A	Kyphon, Inc.	2004	209
K093828	Kyph X HV-R Bone Cement	Medtronic, Inc.	2010	167
K102397	Kyphon Xpede Bone Cement	Medtronic	2011	165
K042415	Mendec Spine	Tecres S.P.A.	2005	28
K042168	CONCORD Radiopaque Bone Cement	Globus Medical, Inc.	2005	6
K122175	Mendec Spine HV, Mendec Spine HV System	Tecres S.P.A.	2013	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 10, 2009	Not classified	Z-1625-2011	Other	Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.
Nov 10, 2009	Not classified	Z-1624-2011	Other	Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K041584 (Kyphon, Inc., 2004) has gone furthest, with 209 descendants of its own.
3 other devices also cite its predicate K002652.

How does its category compare?

All NDN devices

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

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 KyphX® HV-R Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033801 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033801: Kyphx HV-R, Model C01A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033801

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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