510(k) · Cleared
ClearedKyphon Xpander II Inflatable Bone Tamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Oct 14, 2010 as substantially equivalent to K041454 (Kyphon, Inc., 2004) after a 104-day review. Its family tree reaches back 3 generations to 1998. 5 later devices descend from it.
- Decided
- Oct 14, 2010
- Review
- 104 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981251 (1998). 4 ancestors in all. 5 later devices descend from it, 2 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 deviceK101864 Kyphon Xpander II Inflatable Bone TampMedtronic · 2010
- Descendant · cites it directly · 3 of its ownK123771 Kyphon Express II Inflatable Bone TampsMedtronic · 2012
- Descendant · 2 generations on · 1 of its ownK172116 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker…Stryker Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK191596 Arcadia Balloon CatheterMerit Medical Systems, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK181752 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker…Stryker Corporation · 2018
- Descendant · cites it directly · 0 of its ownK122503 Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon…Neuro Therm, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K123771Kyphon Express II Inflatable Bone TampsMedtronic · 2012 · cites it directly3descendants
- K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation · 2018 · 2 generations on1descendant
- K191596Arcadia Balloon CatheterMerit Medical Systems, Inc. · 2019 · 2 generations on0descendants
- K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation · 2018 · 3 generations on0descendants
- K122503Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon Inflatable Bone…Neuro Therm, Inc. · 2013 · cites it directly0descendants
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) | K101864 | Kyphon Xpander II Inflatable Bone Tamp | Medtronic | 2010 | — |
| +1 | K123771 | Kyphon Express II Inflatable Bone Tamps | Medtronic | 2012 | — |
| +2 | K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS… | Stryker Corporation | 2018 | — |
| +2 | K191596 | Arcadia Balloon Catheter | Merit Medical Systems, Inc. | 2019 | — |
| +3 | K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS… | Stryker Corporation | 2018 | — |
| +1 | K122503 | Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon… | Neuro Therm, Inc. | 2013 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 1…standards, are not applicable to the KYPHON Xpander"' II Inflatable Bone Tamps. Predicate Devices: KyphX t Xpander Inflatable Bone Tamp (K04 1454) Intended Use: The KYPHON XpanderTM II Inflatable Bone Tamp is intended to be 'used as a co… | 2004 |
What descends from it? (5)
2 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 12 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K123771 (Medtronic, 2012) has gone furthest, with 3 descendants of its own.
- 22 other devices also cite its predicate K041454.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The KYPHON Xpander TM II Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures) hand, tibia, radius and calcaneus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101864 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101864: Kyphon Xpander II Inflatable Bone Tamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101864
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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