510(k) · Cleared
ClearedStryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · HRX Arthroscope
Cleared on Dec 21, 2018 as substantially equivalent to K172116 (Stryker Corporation, 2018) and 1 other predicate after a 172-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Dec 21, 2018
- Review
- 172 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K981251 (1998). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 7 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 6 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 5 generations backK093419 Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10…Stryker Instruments, Instruments Div. · 2010
- 4 generations backK103807 Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation · 2011
- 3 generations backK113477 Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div. · 2012
- 2 generations backK123942 Stryker Ivas Balloon CatheterStryker Corporation · 2013 · Recalled
- 1 generation backK172116 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker…Stryker Corporation · 2018
- This deviceK181752 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker…Stryker Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −7 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −6 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −5 | K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500… | Stryker Instruments, Instruments Div. | 2010 | — |
| −4 | K103807 | Ivas 2-10MM (10 Guage) Ballon Catheter | Stryker Corporation | 2011 | — |
| −3 | K113477 | Ivas 20MM (10 Gauge) Balloon Catheter | Stryker Instruments, Instruments Div. | 2012 | — |
| −2 | K123942 | Stryker Ivas Balloon Catheter | Stryker Corporation | 2013 | 1 |
| −1 | K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS… | Stryker Corporation | 2018 | — |
| 0 (this device) | K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS… | Stryker Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Summary page 4…e 1 Predicate Device Table Predicate Devices Stryker iVAS ® Elite Balloon Catheter K172116 Primary Predicate Stryker iVAS® Elite Balloon Catheter Stryker iVAS® Balloon Catheter… | 2018 |
| * | K123942 | Stryker Ivas Balloon CatheterSummary page 4…K172116 Primary Predicate Stryker iVAS® Elite Balloon Catheter Stryker iVAS® Balloon Catheter K123942 Secondary Predicate Stryker iVAS® Balloon Catheter 4. Device Description The Stryker iVAS ® Elite Ballo… | 2013 |
| † | K093429 | Unnamed device |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 13 ancestors have a recall of any class.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Stryker iVAS® Elite Inflatable Vertebral Augmentation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181752: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181752
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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