510(k) · Cleared
ClearedVertecem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teknimed, S.A. · NDN Cement, Bone, Vertebroplasty
Cleared on Dec 21, 2009 after a 305-day review. The FDA summary names no predicate by number. 49 later devices descend from it.
- Decided
- Dec 21, 2009
- Review
- 305 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 4 citing it directly.
- This deviceK090435 VertecemTeknimed, S.A. · 2009
- Descendant · cites it directly · 42 of its ownK161114 HIGH V+Teknimed Sas · 2017 · Recalled
- Descendant · 2 generations on · 41 of its ownK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- Descendant · 2 generations on · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- Descendant · 3 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- Descendant · cites it directly · 18 of its ownK103433 F20Teknimed, S.A. · 2011
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K161114HIGH V+Teknimed Sas · 2017 · cites it directly42descendants
- K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018 · 2 generations on41descendants
- K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · 2 generations on28descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 3 generations on27descendants
- K103433F20Teknimed, S.A. · 2011 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090435 | Vertecem | Teknimed, S.A. | 2009 | — |
| +1 | K161114 | HIGH V+ | Teknimed Sas | 2017 | 1 |
| +2 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| +2 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| +3 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| +1 | K103433 | F20 | Teknimed, S.A. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 5 | 0 |
| 2026 | 9 | 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?
The FDA summary names no predicate by number.
What descends from it? (49)
See all 494 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?
- Of its descendants, K161114 (Teknimed Sas, 2017) has gone furthest, with 42 descendants of its own.
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?
The Vertecem Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090435: Vertecem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090435
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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