510(k) · Cleared
ClearedInflatable Bone Tamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Jul 1, 2009 as substantially equivalent to K041454 (Kyphon, Inc., 2004) and 2 other predicates after a 154-day review. Its family tree reaches back 3 generations to 1998. 24 later devices descend from it.
- Decided
- Jul 1, 2009
- Review
- 154 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K981251 (1998). 6 ancestors in all. 24 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 2 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 1 generation backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- This deviceK090211 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 · 8 of its ownK131820 Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon…Care Fusion · 2013
- Descendant · cites it directly · 8 of its ownK122533 Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK140937 Osseoflex SBOsseon, LLC · 2014
- Descendant · 2 generations on · 6 of its ownK141930 Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC · 2014
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K093463Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010 · cites it directly23descendants
- 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 · cites it directly8descendants
- K140937Osseoflex SBOsseon, LLC · 2014 · 2 generations on7descendants
- K141930Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −2 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −1 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| 0 (this device) | K090211 | Inflatable Bone Tamp | Cardinal Health, Inc. | 2009 | — |
| +1 | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | Care Fusion | 2010 | — |
| +1 | K131820 | Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G… | Care Fusion | 2013 | — |
| +1 | K122533 | Osseoflex SB Inflatable Bone Tamp | Osseon Therapeutics, Inc. | 2012 | — |
| +2 | K140937 | Osseoflex SB | Osseon, LLC | 2014 | — |
| +2 | K141930 | Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2ML | Osseon, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 1…Class II per 21 CFR §888.3027, Procode NDN:I Predicate Devices: Kyphx Inflatable Bone Tamp, K041454, K981251 Radiopaque Bone Cement,… | 2004 |
| * | K981251 | Kyphon Inflatable Bone TampSummary page 1…NDN:I Predicate Devices: Kyphx Inflatable Bone Tamp, K041454, K981251 Radiopaque Bone Cement, K043518 Description: T… | 1998 |
| * | K043518 | Radiopaque Bone CementSummary page 1…Kyphx Inflatable Bone Tamp, K041454, K981251 Radiopaque Bone Cement, K043518 Description: The Inflatable Bone Tamp (11BT) was… | 2005 |
What descends from it? (24)
See all 245 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | 2010 | 23 |
| K131820 | Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax… | 2013 | 8 |
| K122533 | Osseoflex SB Inflatable Bone Tamp | 2012 | 8 |
| K131824 | Avaflex Vertebral Balloon System | 2013 | 3 |
| K110604 | VBB System | 2011 | 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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K093463 (Care Fusion, 2010) has gone furthest, with 23 descendants of its own.
- 22 other devices also cite its predicate K041454.
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?
Intended for the reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty (for use with Cardinal Health Radiopaque Bone Cement).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090211: Inflatable Bone Tamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090211
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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