510(k) · Cleared
ClearedVertaplex HV (Single Pack and Dual Pack)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · NDN Cement, Bone, Vertebroplasty
Cleared on Oct 23, 2009 as substantially equivalent to K072118 (Stryker Corp., 2007) after a 142-day review. Its family tree reaches back 2 generations to 2004. 59 later devices descend from it.
- Decided
- Oct 23, 2009
- Review
- 142 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032945 (2004). 59 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK032945 Simplex XStryker Corp. · 2004 · Recalled
- 1 generation backK072118 Stryker Vertaplex Radiopaque Bone CementStryker Corp. · 2007
- This deviceK091606 Vertaplex HV (Single Pack and Dual Pack)Stryker Corp. · 2009
- Descendant · cites it directly · 53 of its ownK150582 Vertaplex® High Viscosity (HV) Radiopaque Bone CementStryker Corporation · 2015 · Recalled
- Descendant · 2 generations on · 52 of its ownK163032 Kyphon Xpede Bone CementMedtronic, Inc. · 2017
- Descendant · 3 generations on · 51 of its ownK180700 KYPHON HV-R Bone CementMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 3 generations on · 50 of its ownK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 4 generations on · 41 of its ownK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K150582Vertaplex® High Viscosity (HV) Radiopaque Bone CementStryker Corporation · 2015 · cites it directly53descendants
- K163032Kyphon Xpede Bone CementMedtronic, Inc. · 2017 · 2 generations on52descendants
- K180700KYPHON HV-R Bone CementMedtronic Sofamor Danek USA, Inc. · 2018 · 3 generations on51descendants
- K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2019 · 3 generations on50descendants
- K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020 · 4 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032945 | Simplex X | Stryker Corp. | 2004 | 2 |
| −1 | K072118 | Stryker Vertaplex Radiopaque Bone Cement | Stryker Corp. | 2007 | — |
| 0 (this device) | K091606 | Vertaplex HV (Single Pack and Dual Pack) | Stryker Corp. | 2009 | — |
| +1 | K150582 | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement | Stryker Corporation | 2015 | 1 |
| +2 | K163032 | Kyphon Xpede Bone Cement | Medtronic, Inc. | 2017 | — |
| +3 | K180700 | KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +3 | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +4 | K193011 | CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 8 | 0 |
| 2026 | 17 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K072118 | Stryker Vertaplex Radiopaque Bone CementSummary page 1…Polymethylmethacrylate (PMMA) Bone Cement Regulation Number: §888.3027 Predicate Device: Stryker Vertaplex Radiopaque Bone Cement (K072118) Device Description: Vertaplex HV is Polymethyl Methacrylate cement used for the treatment of… | 2007 |
What descends from it? (59)
See all 592 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K150582 (Stryker Corporation, 2015) has gone furthest, with 53 descendants of its own.
- 1 other device also cites its predicate K072118.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 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 HV Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or 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/K091606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091606: Vertaplex HV (Single Pack and Dual Pack).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091606
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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