510(k) · Cleared
Recalled · Class II · 2020Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyphon, Inc. · HRX Arthroscope
Cleared on Feb 14, 2001 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 78 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 14, 2001
- Review
- 19 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 3
- Predicates
- 0
78 later devices descend from it, 8 citing it directly.
- This deviceK010246 Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable…Kyphon, Inc. · 2001
- Descendant · cites it directly · 73 of its ownK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 24 of its ownK090211 Inflatable Bone TampCardinal Health, Inc. · 2009
- Descendant · 2 generations on · 23 of its ownK093463 Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010
- Descendant · 2 generations on · 22 of its ownK103064 Avamax Vertebral BalloonCare Fusion · 2011
- Descendant · cites it directly · 16 of its ownK032358 B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd. · 2003
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · cites it directly73descendants
- K090211Inflatable Bone TampCardinal Health, Inc. · 2009 · 2 generations on24descendants
- K093463Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010 · 2 generations on23descendants
- K103064Avamax Vertebral BalloonCare Fusion · 2011 · 2 generations on22descendants
- K032358B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd. · 2003 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp… | Kyphon, Inc. | 2001 | — |
| +1 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| +2 | K090211 | Inflatable Bone Tamp | Cardinal Health, Inc. | 2009 | — |
| +2 | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | Care Fusion | 2010 | — |
| +2 | K103064 | Avamax Vertebral Balloon | Care Fusion | 2011 | — |
| +1 | K032358 | B-Twin Bone Expander System (B-Twin BE System) | Disc-O-Tech Medical Technologies, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (78)
See all 788 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | 2004 | 73 |
| K032358 | B-Twin Bone Expander System (B-Twin BE System) | 2003 | 16 |
| K034037 | Sky Bone Expander System | 2004 | 15 |
| K132817 | Kiva VCF Treatment System | 2014 | 9 |
| K122533 | Osseoflex SB Inflatable Bone Tamp | 2012 | 8 |
| K133669 | Medinaut Kyphoplasty System | 2014 | 7 |
| K122503 | Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon Inflatable Bone… | 2013 | 0 |
| K040939 | Sky Bone Expander System (Sky System) | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2020 | Class II | Z-2389-2020 | Under Investigation by firm | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the… |
| Apr 24, 2020 | Class II | Z-2391-2020 | Under Investigation by firm | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the… |
| Apr 24, 2020 | Class II | Z-2390-2020 | Under Investigation by firm | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041454 (Kyphon, Inc., 2004) has gone furthest, with 73 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010246
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026