510(k) · Cleared
ClearedIvas 20MM (10 Gauge) Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments, Instruments Div. · NDN Cement, Bone, Vertebroplasty
Cleared on Jan 6, 2012 as substantially equivalent to K103807 (Stryker Corporation, 2011) and 2 other predicates after a 44-day review. Its family tree reaches back 5 generations to 1998. 7 later devices descend from it.
- Decided
- Jan 6, 2012
- Review
- 44 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K981251 (1998). 6 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 4 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 3 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 2 generations backK093419 Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10…Stryker Instruments, Instruments Div. · 2010
- 1 generation backK103807 Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation · 2011
- This deviceK113477 Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div. · 2012
- Descendant · cites it directly · 5 of its ownK130430 Ivas 10MM and 15MM Balloon CatheterStryker Corporation · 2013 · Recalled
- Descendant · cites it directly · 5 of its ownK123942 Stryker Ivas Balloon CatheterStryker Corporation · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK152557 Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. · 2016
- Descendant · 2 generations on · 1 of its ownK172116 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker…Stryker Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK172214 Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130430Ivas 10MM and 15MM Balloon CatheterStryker Corporation · 2013 · cites it directly5descendants
- K123942Stryker Ivas Balloon CatheterStryker Corporation · 2013 · cites it directly5descendants
- K152557Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. · 2016 · cites it directly2descendants
- K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation · 2018 · 2 generations on1descendant
- K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −4 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −3 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −2 | K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500… | Stryker Instruments, Instruments Div. | 2010 | — |
| −1 | K103807 | Ivas 2-10MM (10 Guage) Ballon Catheter | Stryker Corporation | 2011 | — |
| 0 (this device) | K113477 | Ivas 20MM (10 Gauge) Balloon Catheter | Stryker Instruments, Instruments Div. | 2012 | — |
| +1 | K130430 | Ivas 10MM and 15MM Balloon Catheter | Stryker Corporation | 2013 | 1 |
| +1 | K123942 | Stryker Ivas Balloon Catheter | Stryker Corporation | 2013 | 1 |
| +1 | K152557 | Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | 2016 | — |
| +2 | K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS… | Stryker Corporation | 2018 | — |
| +2 | K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.R.L. | 2017 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 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 NDN? 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 NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 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 |
|---|---|---|---|
| * | K103807 | Ivas 2-10MM (10 Guage) Ballon CatheterSummary page 1…§588.3027 Product Code: HRX NON Predicate Device: Stryker@ iVAS Balloon Catheter (K1 03807) Stryker®D iVAS Balloon Catheter (K093419) Kyphx Xpander Infl… | 2011 |
| * | K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas…Summary page 1…NON Predicate Device: Stryker@ iVAS Balloon Catheter (K1 03807) Stryker®D iVAS Balloon Catheter (K093419) Kyphx Xpander Inflatable Bone Tamps (K041454) Device Description: The Stryker@… | 2010 |
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 1…on Catheter (K1 03807) Stryker®D iVAS Balloon Catheter (K093419) Kyphx Xpander Inflatable Bone Tamps (K041454) Device Description: The Stryker@ iVAS balloon catheter is a bone tamp with an inflatable component… | 2004 |
What descends from it? (7)
3 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 14 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K130430 (Stryker Corporation, 2013) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K103807.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, 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 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Stryker@ VAS Inflatable Vertebral Augmentation System (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 Poly methylniethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113477: Ivas 20MM (10 Gauge) 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/K113477
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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