510(k) · Cleared
Recalled · Class II · 2020Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyphon, Inc. · HRX Arthroscope
Cleared on Jul 9, 2004 as substantially equivalent to K032212 (Kyphon, Inc., 2003) and 2 other predicates after a 38-day review. Its family tree reaches back 2 generations to 1998. 73 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 9, 2004
- Review
- 38 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 2 generations to K981251 (1998). 3 ancestors in all. 73 later devices descend from it, 23 citing it directly.
- Root · 2 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 1 generation backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- This deviceK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004
- 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 · 13 of its ownK093419 Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10…Stryker Instruments, Instruments Div. · 2010
- Descendant · cites it directly · 12 of its ownK053336 Staxx FX SystemSpine Wave, Inc. · 2006
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · 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
- K093419Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas…Stryker Instruments, Instruments Div. · 2010 · cites it directly13descendants
- K053336Staxx FX SystemSpine Wave, Inc. · 2006 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −1 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| 0 (this device) | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | — |
| +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 | K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500… | Stryker Instruments, Instruments Div. | 2010 | — |
| +1 | K053336 | Staxx FX System | Spine Wave, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (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 |
|---|---|---|---|
| * | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17ASummary page 4…Vice President, Clinical Research & Regulatory Affairs Predicate Device(s): KyphX® Directional Inflatable Bone Tamp, K032212 KyphX® Inflatable Bone Tamp, K010246 Kyphon Inflatable… | 2003 |
| * | K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3…Summary page 4…gulatory Affairs Predicate Device(s): KyphX® Directional Inflatable Bone Tamp, K032212 KyphX® Inflatable Bone Tamp, K010246 Kyphon Inflatable Bone Tamp, K981251 Device Description: The KyphX® Inflat… | 2001 |
| * | K981251 | Kyphon Inflatable Bone TampSummary page 4…Inflatable Bone Tamp, K032212 KyphX® Inflatable Bone Tamp, K010246 Kyphon Inflatable Bone Tamp, K981251 Device Description: The KyphX® Inflatable Bone Tamps are the identified pr… | 1998 |
| † | K033801 | Kyphx HV-R, Model C01A | 2004 |
What descends from it? (73)
See all 7323 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 |
| K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas… | 2010 | 13 |
| K053336 | Staxx FX System | 2006 | 12 |
| K103807 | Ivas 2-10MM (10 Guage) Ballon Catheter | 2011 | 9 |
| K122533 | Osseoflex SB Inflatable Bone Tamp | 2012 | 8 |
| K133669 | Medinaut Kyphoplasty System | 2014 | 7 |
| K113477 | Ivas 20MM (10 Gauge) Balloon Catheter | 2012 | 7 |
| K110998 | Affirm (TM) VCF System | 2011 | 6 |
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… |
| Mar 23, 2011 | Not classified | Z-3175-2011 | Employee error | Device was shipped past the labeled expiration date. |
| Feb 4, 2009 | Not classified | Z-1209-2009 | Process change control | Product not sterile: 10 units were released for distribution without undergoing sterilization process. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 5.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K090211 (Cardinal Health, Inc., 2009) has gone furthest, with 24 descendants of its own.
- 3 other devices also cite its predicate K032212.
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 | — |
What is it indicated for?
KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.
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/K041454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041454
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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