510(k) · Cleared
ClearedVertecem II Cement Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aap Biomaterials GmbH · NDN Cement, Bone, Vertebroplasty
Cleared on Oct 19, 2012 as substantially equivalent to K090435 (Teknimed, S.A., 2009) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Oct 19, 2012
- Review
- 114 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P810020 (1984). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 3 generations backK030903 OsteopalHeraeus Kulzer GmbH & Co. KG · 2003
- 2 generations backK050085 Osteopal VHeraeus Kulzer,GmbH · 2005
- 1 generation backK090460 Bonos InjectAap Biomaterials GmbH · 2009
- This deviceK121876 Vertecem II Cement KitAap Biomaterials GmbH · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −3 | K030903 | Osteopal | Heraeus Kulzer GmbH & Co. KG | 2003 | — |
| −2 | K050085 | Osteopal V | Heraeus Kulzer,GmbH | 2005 | — |
| −1 | K090460 | Bonos Inject | Aap Biomaterials GmbH | 2009 | — |
| 0 (this device) | K121876 | Vertecem II Cement Kit | Aap Biomaterials GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090435 | VertecemSummary page 1…faturer Device Name 510(k) # Teknimed S.A.S. Vertecemn (K090435) Manufaturer Device Name 510(k) # aap Biomaterials… | 2009 |
| * | K090460 | Bonos InjectSummary page 1…faturer Device Name 510(k) # aap Biomaterials Bon~s Inject (K090460) 5-1 __________ _____… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 3 other devices also cite its predicate K090435.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Vertecemn 11 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 osteoporoisis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121876 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121876: Vertecem II Cement Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121876
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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