510(k) Report

510(k) · Cleared

Cleared

Kyph X HV-R Bone Cement

K093828510(k) SpecialCleared Aug 12, 2010241-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, Inc. · NDN Cement, Bone, Vertebroplasty

Cleared on Aug 12, 2010 as substantially equivalent to K041584 (Kyphon, Inc., 2004) and 1 other predicate after a 241-day review. Its family tree reaches back 3 generations to 2001. 167 later devices descend from it.

Decided
Aug 12, 2010
Review
241 days
Class
Class II
Product code
NDN
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K002652 (2001). 4 ancestors in all. 167 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2015: 2 descendants cleared2011: 1 descendant cleared2013: 1 descendant cleared2017: 6 descendants cleared2022: 16 descendants cleared2023: 25 descendants cleared2016: 3 descendants cleared2021: 15 descendants cleared2019: 7 descendants cleared2018: 8 descendants cleared2020: 14 descendants cleared2024: 22 descendants cleared2026: 27 descendants cleared2025: 20 descendants 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) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 14 descendants4 generations forward: 32 descendants5 generations forward: 51 descendants6 generations forward: 42 descendants7 generations forward: 15 descendants8 generations forward: 4 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+5
  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 deviceK093828 Kyph X HV-R Bone CementMedtronic, Inc. · 2010
  5. Descendant · cites it directly · 165 of its ownK102397 Kyphon Xpede Bone CementMedtronic · 2011
  6. Descendant · cites it directly · 162 of its ownK150460 KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015
  7. Descendant · 2 generations on · 159 of its ownK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
  8. Descendant · 3 generations on · 106 of its ownK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
  9. Descendant · 3 generations on · 91 of its ownK170347 CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017

Showing 5 of 167 descendants. See all descendants

Descendants cleared per year

2011: 12013: 12015: 22016: 32017: 62018: 82019: 72020: 142021: 152022: 162023: 252024: 222025: 202026: 27
2011high 27 (2026) · low 0 (2012)2026

Most influential descendants

Showing 5 of 167 · See all
  • K102397Kyphon Xpede Bone CementMedtronic · 2011 · cites it directly165descendants
  • K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015 · cites it directly162descendants
  • K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016 · 2 generations on159descendants
  • K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl · 2016 · 3 generations on106descendants
  • K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017 · 3 generations on91descendants
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)K093828Kyph X HV-R Bone CementMedtronic, Inc.2010—
+1K102397Kyphon Xpede Bone CementMedtronic2011—
+1K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc.2015—
+2K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016—
+3K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated…Medos International Sàrl2016—
+3K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201310
201520
201630
201760
201880
201970
2020140
2021150
2022160
2023250
2024220
2025200
2026270
FIG. 1 — Lineage of K093828, 2001–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K041584Kyphx HV-R Bone Cement, Model C01A
Summary page 1
…,under section 514 for performance standards, are not applicable to the KyphX HV-R® Bone Cement. Predicate Devices: K041584 KyphX HV- R® Bone Cement VR®Bone Cement K033801 KyphX W-…
Kyphon, Inc.20042
*K033801Kyphx HV-R, Model C01A
Summary page 1
…HV-R® Bone Cement. Predicate Devices: K041584 KyphX HV- R® Bone Cement VR®Bone Cement K033801 KyphX W-i Intended Use: KyphX HV-R® Bone Cement is indicated for the treatment of pa…
Kyphon, Inc.20042

Also cleared against K041584: 9 other devices →

What descends from it? (167)

See all 167

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

NumberDeviceApplicantDecidedDescendants
K102397Kyphon Xpede Bone CementMedtronic2011165
K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc.2015162
K122175Mendec Spine HV, Mendec Spine HV SystemTecres S.P.A.20131

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 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
  • 4 of the 4 ancestors have a recall of any class.
  • Of its descendants, K102397 (Medtronic, 2011) has gone furthest, with 165 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. 2010, this device’s year, is highlighted.

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?

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

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
  • K053336Staxx FX SystemSpine Wave, Inc. · 2006
  • K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 20068 recalls
  • K043593Spine-Fix Biomimetic Bone CementTeknimed, S.A. · 2006

More from Medtronic, Inc.

6,442 FDA decisions under this applicant name. See the company

  • P220026/S019Symplicity G3 Renal Denervation RF GeneratorMedtronic, Inc. · 2026
  • P240036/S007OmniaSecure™ MRI SureScan™ Lead Model 3930MMedtronic, Inc. · 2026
  • P010015/S591Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena…Medtronic, Inc. · 2026
  • P980035/S848Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG…Medtronic, Inc. · 2026
  • P860004/S462SynchroMed™ Infusion System, Ascenda ™ Intrathecal CathetersMedtronic, Inc. · 2026

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/K093828 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093828: Kyph X HV-R Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093828

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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