510(k) Report

510(k) · Cleared

Cleared

Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas 3-10MM (8 Gauge)Balloon Catheter, Ivas

K093419510(k) TraditionalCleared Mar 18, 2010136-day reviewClass II21 CFR 888.3027

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Instruments, Instruments Div. · NDN Cement, Bone, Vertebroplasty

Cleared on Mar 18, 2010 as substantially equivalent to K041454 (Kyphon, Inc., 2004) after a 136-day review. Its family tree reaches back 3 generations to 1998. 13 later devices descend from it.

Decided
Mar 18, 2010
Review
136 days
Class
Class II
Product code
NDN
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K981251 (1998). 4 ancestors in all. 13 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2012: 2 descendants cleared2011: 2 descendants cleared2016: 1 descendant cleared2013: 3 descendants cleared2014: 1 descendant cleared2018: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant clearedK981251 · Kyphon Inflatable Bone Tamp · Kyphon, Inc. · 1998 · recalledK032212 · Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A · Kyphon, Inc. · 2003K041454 · Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A · Kyphon, Inc. · 2004 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K041454 · Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A · Kyphon, Inc. · 2004 · recalledK032212 · Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A · Kyphon, Inc. · 2003K981251 · Kyphon Inflatable Bone Tamp · Kyphon, Inc. · 1998 · recalled0
  1. Root · 3 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
  2. 2 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
  3. 1 generation backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
  4. This deviceK093419 Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10…Stryker Instruments, Instruments Div. · 2010
  5. Descendant · cites it directly · 9 of its ownK103807 Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation · 2011
  6. Descendant · cites it directly · 7 of its ownK113477 Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div. · 2012
  7. Descendant · cites it directly · 5 of its ownK130430 Ivas 10MM and 15MM Balloon CatheterStryker Corporation · 2013 · Recalled
  8. Descendant · cites it directly · 5 of its ownK123942 Stryker Ivas Balloon CatheterStryker Corporation · 2013 · Recalled
  9. Descendant · cites it directly · 3 of its ownK113154 Ivas Balloon CatheterStryker Corporation · 2012

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2011: 22012: 22013: 32014: 12016: 12017: 12018: 22020: 1
2011high 3 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 13 · See all
  • K103807Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation · 2011 · cites it directly9descendants
  • K113477Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div. · 2012 · cites it directly7descendants
  • K130430Ivas 10MM and 15MM Balloon CatheterStryker Corporation · 2013 · cites it directly5descendants
  • K123942Stryker Ivas Balloon CatheterStryker Corporation · 2013 · cites it directly5descendants
  • K113154Ivas Balloon CatheterStryker Corporation · 2012 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K981251Kyphon Inflatable Bone TampKyphon, Inc.19983
−2K032212Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc.2003—
−1K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc.20045
0 (this device)K093419Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500…Stryker Instruments, Instruments Div.2010—
+1K103807Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation2011—
+1K113477Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div.2012—
+1K130430Ivas 10MM and 15MM Balloon CatheterStryker Corporation20131
+1K123942Stryker Ivas Balloon CatheterStryker Corporation20131
+1K113154Ivas Balloon CatheterStryker Corporation2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201220
201330
201410
201610
201710
201820
202010
FIG. 1 — Lineage of K093419, 1998–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A
Summary page 1
…§888.3027 Product Code: HRX NDN Predicate Device: Kyphx Xpander Inflatable Bone Tamps (K041454) Device Description: The Stryker® WAS balloon catheter is a bone tamp with an inflatable component…
Kyphon, Inc.20045

Also cleared against K041454: 22 other devices →

What descends from it? (13)

See all 13

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103807Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation20119
K113477Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div.20127
K130430Ivas 10MM and 15MM Balloon CatheterStryker Corporation20135
K123942Stryker Ivas Balloon CatheterStryker Corporation20135
K113154Ivas Balloon CatheterStryker Corporation20123
K152557Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L.20162
K110604VBB SystemSynthes20111
K141419ZvplastyZavation, LLC20140

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, K103807 (Stryker Corporation, 2011) has gone furthest, with 9 descendants of its own.
  • 22 other devices also cite its predicate K041454.

How does its category compare?

All NDN devices

NDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · NDN

2in 2025

2007: 92008: 12009: 62010: 52011: 112012: 72013: 72014: 72015: 62016: 42017: 52018: 32019: 22020: 42021: 22022: 22023: 22024: 32025: 22026 (partial year): 1
2007high 11 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDN

90in 2024

2007: 128 days median2009: 211 days median2010: 215 days median2011: 164 days median2012: 90 days median2013: 118 days median2014: 106 days median2015: 76 days median2016: 154 days median2017: 125 days median2018: 111 days median2020: 157 days median2024: 90 days median
2007high 215 (2010) · low 76 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NDN

4in 2013

2009: 12013: 4
2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NDN

626in 2025

2007: 212008: 392009: 702010: 3962011: 982012: 892013: 2422014: 2312015: 2042016: 1822017: 1912018: 1442019: 2272020: 2122021: 3442022: 2702023: 3112024: 4542025: 626
2007high 626 (2025) · low 21 (2007)2025

MAUDE reports naming product code NDN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079128021
20081—039
20096211170
201052150396
201111164098
2012790089
201371184242
201471060231
20156760204
201641540182
201751250191
201831110144
20192—0227
202041570212
20212—0344
20222—0270
20232—0311
20243900454
20252—0626
20261—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 Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K041454

22 other devices cite the same predicate.

  • K202027Balex bone Expander SystemTaeyeon Medical Co., Ltd. · 2021
  • K151532KYPHON ELEMENT Inflatable Bone TampMedtronic, Inc. · 2015
  • K132620Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty Catheter (Balloon Lenght: 15 MM)…Pan Medical, Ltd. · 2014
  • K133669Medinaut Kyphoplasty SystemImedicom · 2014
  • K122503Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon Inflatable Bone Tamp-15 MM Balloon…Neuro Therm, Inc. · 2013
  • K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC · 2013

More from Stryker Instruments, Instruments Div.

6 FDA decisions under this applicant name. See the company

  • K123178Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013
  • K113477Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div. · 2012
  • K072702Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008
  • K073017Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 20071 recall
  • K070078Stryker T4 Hytrel TogaStryker Instruments, Instruments Div. · 200727 recalls

Recent decisions in NDN

The NDN category page

  • K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed, Ltd. · 2026
  • K250637VCFix Spinal SystemAmber Implants · 2025
  • K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed, Ltd. · 2025
  • K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed, Ltd. · 2024
  • K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd. · 2024

https://510kreport.com/device/K093419 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093419: Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas 3-10MM (8 Gauge)Balloon Catheter, Ivas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093419

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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