510(k) · Cleared
ClearedAVAflex Vertebral Balloon System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · HRX Arthroscope
Cleared on Nov 24, 2015 as substantially equivalent to K131824 (Care Fusion, 2013) and 1 other predicate after a 210-day review. Its family tree reaches back 6 generations to 1998. 1 later device descends from it.
- Decided
- Nov 24, 2015
- Review
- 210 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K981251 (1998). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 5 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 4 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 3 generations backK090211 Inflatable Bone TampCardinal Health, Inc. · 2009
- 2 generations backK093463 Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010
- 1 generation backK131824 Avaflex Vertebral Balloon SystemCare Fusion · 2013
- This deviceK151125 AVAflex Vertebral Balloon SystemCare Fusion · 2015
- Descendant · cites it directly · 0 of its ownK162062 AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −5 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −4 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −3 | K090211 | Inflatable Bone Tamp | Cardinal Health, Inc. | 2009 | — |
| −2 | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | Care Fusion | 2010 | — |
| −1 | K131824 | Avaflex Vertebral Balloon System | Care Fusion | 2013 | — |
| 0 (this device) | K151125 | AVAflex Vertebral Balloon System | Care Fusion | 2015 | — |
| +1 | K162062 | AVAmax Vertebral Balloon, AVAflex Vertebral Balloon | Stryker Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 |
|---|---|---|---|
| * | K131824 | Avaflex Vertebral Balloon SystemSummary page 4…per 21CFR §888.1100, Procode HRX Class Il per 21CFR §888.3027, Procode NDN Legally marketed device(s) to which equivalence is claimed CareFusion Inflatable Bone Tamps, K131824 Radiopaque Bone Cement, K043518 Reason for 510(k) submission Modifications to device Device description The Inflatable Bone T… | 2013 |
| * | K043518 | Radiopaque Bone CementSummary page 4…Class Il per 21CFR §888.3027, Procode NDN Legally marketed device(s) to which equivalence is claimed CareFusion Inflatable Bone Tamps, K131824 Radiopaque Bone Cement, K043518 Reason for 510(k) submission Modifications to device Device description The Inflatable Bone Tamp (IBT) was designed for use i… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162062 | AVAmax Vertebral Balloon, AVAflex Vertebral Balloon | 2016 | 0 |
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 17 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K162062 (Stryker Corporation, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K131824.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151125: AVAflex Vertebral Balloon System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151125
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