510(k) Report

510(k) · Cleared

Cleared

Vertebroplastic Radiopaque Bone Cement

K043406510(k) TraditionalCleared Jul 15, 2005217-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

Depuy Spine, Inc. · NDN Cement, Bone, Vertebroplasty

Cleared on Jul 15, 2005 as substantially equivalent to K041584 (Kyphon, Inc., 2004) and 3 other predicates after a 217-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.

Decided
Jul 15, 2005
Review
217 days
Class
Class II
Product code
NDN
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K002652 (2001). 5 ancestors in all, the oldest K873689 (1987). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1987: 1 other ancestor2007: 1 descendant cleared2020: 1 descendant cleared2011: 1 descendant clearedK002652 · Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii · Stryker Corp. · 2001 · recalled×2: 2 generations cleared close together, K033801 (2004), K041584 (2004) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K041584 · Kyphx HV-R Bone Cement, Model C01A · Kyphon, Inc. · 2004 · recalledK033801 · Kyphx HV-R, Model C01A · Kyphon, Inc. · 2004 · recalledK002652 · Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii · Stryker Corp. · 2001 · recalled0
  1. Root · 3 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
  2. 2 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
  3. 1 generation backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
  4. This deviceK043406 Vertebroplastic Radiopaque Bone CementDepuy Spine, Inc. · 2005
  5. Descendant · cites it directly · 2 of its ownK071927 Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company · 2007
  6. Descendant · 2 generations on · 0 of its ownK201831 CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
  7. Descendant · 2 generations on · 0 of its ownK112907 Confidence High Viscosity Spinal Cement, 16G / 20GMedos International SARL · 2011

Most influential descendants

Showing 3 of 3 · See all
  • K071927Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company · 2007 · cites it directly2descendants
  • K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020 · 2 generations on0descendants
  • K112907Confidence High Viscosity Spinal Cement, 16G / 20GMedos International SARL · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002652Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp.20011
−2K033801Kyphx HV-R, Model C01AKyphon, Inc.20042
−1K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc.20042
0 (this device)K043406Vertebroplastic Radiopaque Bone CementDepuy Spine, Inc.2005—
+1K071927Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company2007—
+2K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.2020—
+2K112907Confidence High Viscosity Spinal Cement, 16G / 20GMedos International SARL2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
202010
FIG. 1 — Lineage of K043406, 2001–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K041584Kyphx HV-R Bone Cement, Model C01A
Summary page 1
…Raynham, Massachusetts 02767-0350 Tel.: (508) 828-2867; Fax: (508) 828-3797 Equivalent to: KyphX*: HV-RT M Bone Cement Model CO lA (K041584) Stryker SpinePlex TM Radiopaque Bone Cement (K032945) Stryker Howmedica Surgical…
Kyphon, Inc.20042
*K032945Simplex X
Summary page 1
…-2867; Fax: (508) 828-3797 Equivalent to: KyphX*: HV-RT M Bone Cement Model CO lA (K041584) Stryker SpinePlex TM Radiopaque Bone Cement (K032945) Stryker Howmedica Surgical Simplex® P Radiopaque pre-packed in ACM and MixEvac lI…
Stryker Corp.20042
*K002652Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii
Summary page 1
…lex TM Radiopaque Bone Cement (K032945) Stryker Howmedica Surgical Simplex® P Radiopaque pre-packed in ACM and MixEvac lI (K002652) Cranioplastic T M, acrylic cranioplasty material (K873689) Device Description: VertebroplasticTM Ra…
Stryker Corp.20011
*K873689Cranioplastic, Acrylic Cranioplasty Material
Summary page 1
…urgical Simplex® P Radiopaque pre-packed in ACM and MixEvac lI (K002652) Cranioplastic T M, acrylic cranioplasty material (K873689) Device Description: VertebroplasticTM Radiopaque Bone Cement is a self-curing, radiopaque, polymethy…
Dentsply Intl.1987—

Also cleared against K041584: 9 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071927Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company20072

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 4 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
  • 4 of the 5 ancestors have a recall of any class.
  • Of its descendants, K071927 (Depuy Spine, A Johnson & Johnson Company, 2007) has gone furthest, with 2 descendants of its own.
  • 9 other devices also cite its predicate K041584.

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

2007: 92008: 12009: 62010: 52011: 112012: 72013: 72014: 72015: 62016: 42017: 52018: 32019: 22020: 42021: 22022: 22023: 22024: 32025: 22026 (partial year): 1
2007high 11 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDN

90in 2024

2007: 128 days median2009: 211 days median2010: 215 days median2011: 164 days median2012: 90 days median2013: 118 days median2014: 106 days median2015: 76 days median2016: 154 days median2017: 125 days median2018: 111 days median2020: 157 days median2024: 90 days median
2007high 215 (2010) · low 76 (2015)2026

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

Recalls per year · NDN

4in 2013

2009: 12013: 4
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

2007: 212008: 392009: 702010: 3962011: 982012: 892013: 2422014: 2312015: 2042016: 1822017: 1912018: 1442019: 2272020: 2122021: 3442022: 2702023: 3112024: 4542025: 626
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079128021
20081—039
20096211170
201052150396
201111164098
2012790089
201371184242
201471060231
20156760204
201641540182
201751250191
201831110144
20192—0227
202041570212
20212—0344
20222—0270
20232—0311
20243900454
20252—0626
20261—0—

What is it indicated for?

VertebroplasticTM Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangionra), or malignant lesions (metastatic cancers, myeloma).

Indications for use as stated in the FDA summary.

Also cleared against K041584

9 other devices cite the same predicate.

  • K192403VK100 Percutaneous Vertebral Augmentation SystemBonwrx, Ltd. · 2019
  • K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
  • K102397Kyphon Xpede Bone CementMedtronic · 2011
  • K093828Kyph X HV-R Bone CementMedtronic, Inc. · 2010
  • K053336Staxx FX SystemSpine Wave, Inc. · 2006
  • K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 20068 recalls

More from Depuy Spine, Inc.

86 FDA decisions under this applicant name. See the company

  • K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
  • K142185Expedium Verse Spine SystemDepuy Spine, Inc. · 2014
  • K111136Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 20121 recall
  • K121020Viper SystemDepuy Spine, Inc. · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011

Recent decisions in NDN

The NDN category page

  • K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed, Ltd. · 2026
  • K250637VCFix Spinal SystemAmber Implants · 2025
  • K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed, Ltd. · 2025
  • K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed, Ltd. · 2024
  • K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd. · 2024

https://510kreport.com/device/K043406 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043406: Vertebroplastic Radiopaque Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043406

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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