510(k) · Cleared
ClearedRadiopaque Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinalhealth · NDN Cement, Bone, Vertebroplasty
Cleared on May 11, 2005 as substantially equivalent to K032945 (Stryker Corp., 2004) after a 142-day review. Its family tree reaches back 1 generation to 2004. 27 later devices descend from it.
- Decided
- May 11, 2005
- Review
- 142 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032945 (2004). 27 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK032945 Simplex XStryker Corp. · 2004 · Recalled
- This deviceK043518 Radiopaque Bone CementCardinalhealth · 2005
- Descendant · cites it directly · 24 of its ownK090211 Inflatable Bone TampCardinal Health, Inc. · 2009
- Descendant · cites it directly · 23 of its ownK093463 Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010
- Descendant · cites it directly · 22 of its ownK103064 Avamax Vertebral BalloonCare Fusion · 2011
- Descendant · cites it directly · 8 of its ownK131820 Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon…Care Fusion · 2013
- Descendant · 2 generations on · 8 of its ownK122533 Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc. · 2012
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K090211Inflatable Bone TampCardinal Health, Inc. · 2009 · cites it directly24descendants
- K093463Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010 · cites it directly23descendants
- K103064Avamax Vertebral BalloonCare Fusion · 2011 · cites it directly22descendants
- K131820Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax…Care Fusion · 2013 · cites it directly8descendants
- K122533Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc. · 2012 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032945 | Simplex X | Stryker Corp. | 2004 | 2 |
| 0 (this device) | K043518 | Radiopaque Bone Cement | Cardinalhealth | 2005 | — |
| +1 | K090211 | Inflatable Bone Tamp | Cardinal Health, Inc. | 2009 | — |
| +1 | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | Care Fusion | 2010 | — |
| +1 | K103064 | Avamax Vertebral Balloon | Care Fusion | 2011 | — |
| +1 | K131820 | Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G… | Care Fusion | 2013 | — |
| +2 | K122533 | Osseoflex SB Inflatable Bone Tamp | Osseon Therapeutics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K032945 | Simplex XSummary page 1…the vertebral body. Substantial Equivalence: This device is substantially equivalent to Stryker Spineplex Radiopaque Bone Cement (K032945). Description: Radiopaque Bone Cement is a self-curing acrylic that a surgeon uses to… | 2004 |
What descends from it? (27)
See all 276 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090211 | Inflatable Bone Tamp | 2009 | 24 |
| K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | 2010 | 23 |
| K103064 | Avamax Vertebral Balloon | 2011 | 22 |
| K131820 | Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax… | 2013 | 8 |
| K131824 | Avaflex Vertebral Balloon System | 2013 | 3 |
| K151125 | AVAflex Vertebral Balloon System | 2015 | 1 |
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?
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043518: 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/K043518
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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