510(k) · Cleared
Recalled · Class II · 2017Stryker Ivas Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · NDN Cement, Bone, Vertebroplasty
Cleared on Apr 3, 2013 as substantially equivalent to K113477 (Stryker Instruments, Instruments Div., 2012) and 4 other predicates after a 104-day review. Its family tree reaches back 6 generations to 1998. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 3, 2013
- Review
- 104 days
- Class
- Class II
- Product code
- NDN
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 6 generations to K981251 (1998). 8 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 5 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 4 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 3 generations backK093419 Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10…Stryker Instruments, Instruments Div. · 2010
- 2 generations backK103807 Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation · 2011
- 1 generation backK113477 Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div. · 2012
- This deviceK123942 Stryker Ivas Balloon CatheterStryker Corporation · 2013
- Descendant · cites it directly · 2 of its ownK152557 Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. · 2016
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 0 of its ownK200763 Osteo-site Vertebral BalloonIzi Medical · 2020
- Descendant · cites it directly · 0 of its ownK181752 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker…Stryker Corporation · 2018
Most influential descendants
Showing 5 of 5 · See all- 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 · cites it directly1descendant
- K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. · 2017 · 2 generations on1descendant
- K200763Osteo-site Vertebral BalloonIzi Medical · 2020 · 3 generations on0descendants
- K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −5 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −4 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −3 | K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500… | Stryker Instruments, Instruments Div. | 2010 | — |
| −2 | K103807 | Ivas 2-10MM (10 Guage) Ballon Catheter | Stryker Corporation | 2011 | — |
| −1 | K113477 | Ivas 20MM (10 Gauge) Balloon Catheter | Stryker Instruments, Instruments Div. | 2012 | — |
| 0 (this device) | K123942 | Stryker Ivas Balloon Catheter | Stryker Corporation | 2013 | — |
| +1 | K152557 | Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | 2016 | — |
| +1 | 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 | — |
| +3 | K200763 | Osteo-site Vertebral Balloon | Izi Medical | 2020 | — |
| +1 | 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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K113477 | Ivas 20MM (10 Gauge) Balloon CatheterSummary page 1…tebroplasty Regulation Number: §888.1100 §888.3027 3. Legally Marketed Predicate Device(s) 510(k) Number Product Code Trade Name Manufacturer KI 113477 HRX Stryker* WAS Balloon Stryker Instruments NDN Catheter _… | 2012 |
| * | K103807 | Ivas 2-10MM (10 Guage) Ballon CatheterSummary page 1…Manufacturer KI 113477 HRX Stryker* WAS Balloon Stryker Instruments NDN Catheter ____________ K103807 H-RX Stryker® WAS Balloon Stryker Instruments __________NDN Catheter… | 2011 |
| * | K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas…Summary page 1…____________ K103807 H-RX Stryker® WAS Balloon Stryker Instruments __________NDN Catheter ____________ K09341 9 HRX Stryker® iVAS Balloon Stryker Instruments ___________NDN Catheter… | 2010 |
| * | K110998 | Affirm (TM) VCF System | 2011 |
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 2…2Z13 KI 10998 HRX AFFIRMTM VCF System Algea Therapies NDNI K041454 HRX Xpander Inflatable Bone Kyphon Inc.… | 2004 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152557 | Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | 2016 | 2 |
| K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon… | 2018 | 1 |
| K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon… | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2017 | Class II | Z-1253-2018 | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K152557 (G21, S.R.L., 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K113477.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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® iVAS 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 with Cortoss ® and cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Vertebral Compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123942: Stryker Ivas 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/K123942
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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