510(k) · Cleared
Recalled · Class II · 2020Kyphon Inflatable Bone Tamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyphon, Inc. · HRX Arthroscope
Cleared on Jul 2, 1998 after an 87-day review. The FDA summary names its predicate without a number. 124 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 2, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 3
- Predicates
- 0
124 later devices descend from it, 14 citing it directly.
- This deviceK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998
- Descendant · cites it directly · 77 of its ownK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- Descendant · cites it directly · 73 of its ownK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- Descendant · cites it directly · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 2 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 3 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K032212Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003 · cites it directly77descendants
- K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · cites it directly73descendants
- K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · cites it directly44descendants
- K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 2 generations on42descendants
- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 3 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | — |
| +1 | 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 |
| +1 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +2 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +3 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 11 | 0 |
| 2012 | 10 | 0 |
| 2013 | 12 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 8 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 9 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | — | currently marketed bone tamps Named without a submission number | |
| * | — | elevators Named without a submission number | |
| * | — | curettes Named without a submission number | |
| * | — | GSI Surgical Dissector Named without a submission number | |
| * | — | Koros Microdiscectomy Currette Named without a submission number |
What descends from it? (124)
See all 12414 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | 2003 | 77 |
| K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | 2004 | 73 |
| K072302 | Entellus Medical RS-Series System | 2008 | 44 |
| K090211 | Inflatable Bone Tamp | 2009 | 24 |
| K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | 2010 | 23 |
| K103064 | Avamax Vertebral Balloon | 2011 | 22 |
| K032358 | B-Twin Bone Expander System (B-Twin BE System) | 2003 | 16 |
| K034037 | Sky Bone Expander System | 2004 | 15 |
| K122533 | Osseoflex SB Inflatable Bone Tamp | 2012 | 8 |
| K133669 | Medinaut Kyphoplasty System | 2014 | 7 |
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, K032212 (Kyphon, Inc., 2003) has gone furthest, with 77 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 | — |
What is it indicated for?
Kyphon Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction for fractures and/or creation of a void in cancellous bone.
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/K981251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981251: Kyphon 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/K981251
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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