510(k) · Cleared
ClearedAvamax Vertebral Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · NDN Cement, Bone, Vertebroplasty
Cleared on Jan 10, 2011 as substantially equivalent to K041454 (Kyphon, Inc., 2004) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1998. 22 later devices descend from it.
- Decided
- Jan 10, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K981251 (1998). 6 ancestors in all. 22 later devices descend from it, 4 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 deviceK103064 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 · 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
- Descendant · 2 generations on · 4 of its ownK151704 Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- 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
- K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016 · 2 generations on4descendants
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) | K103064 | Avamax Vertebral Balloon | Care Fusion | 2011 | — |
| +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 | — |
| +2 | K151704 | Diplomat® Spinal System | Signus Medizintechnik GmbH | 2016 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K093643 | FDA’s K093643 is Multi- Unit Abutments for Straumann and Astra Tech Implant Systems Our reading of the summary gave K093643, FDA’s number for Multi- Unit Abutments for Straumann and Astra Tech Implant… (Nobel Biocare AB). Its FDA name has none of the distinctive words the summary uses for the device it names, “CareFusion Inflatable Bone Tamp”. Kept off the family tree. Summary page 2…Characteristic New Device Kyphon IBT (K041454) ________________ _______________________ CareFusion Vertebral Balloon (K093643) Compatible cannula 11iG 1OG size Balloon inflation 60% contrast re… | 2010 |
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 1…VBT1 115. VBT1 120 Legally marketed CareFusion Inflatable Bone Tamp, K<093463 device(s) to which Kyphx Inflatable Bone Tamp, K041454, K981251 equlivalence Is Radiopaque Bone Cement, K043518 claimed ______________… | 2004 |
| * | K981251 | Kyphon Inflatable Bone TampSummary page 1…T1 115. VBT1 120 Legally marketed CareFusion Inflatable Bone Tamp, K<093463 device(s) to which Kyphx Inflatable Bone Tamp, K041454, K981251 equlivalence Is Radiopaque Bone Cement, K043518 claimed _______________________… | 1998 |
| * | K043518 | Radiopaque Bone CementSummary page 1…atable Bone Tamp, K<093463 device(s) to which Kyphx Inflatable Bone Tamp, K041454, K981251 equlivalence Is Radiopaque Bone Cement, K043518 claimed ________________________________ Reason for 61 0(k) New Device submission… | 2005 |
What descends from it? (22)
See all 224 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 13 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K131820 (Care Fusion, 2013) has gone furthest, with 8 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. 2011, 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 and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103064: Avamax Vertebral Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103064
Report an extraction error
Are you the manufacturer?
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