510(k) · Cleared
ClearedWinch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G21, S.R.L. · NDN Cement, Bone, Vertebroplasty
Cleared on Feb 23, 2016 as substantially equivalent to K130430 (Stryker Corporation, 2013) and 6 other predicates after a 168-day review. Its family tree reaches back 7 generations to 1998. 2 later devices descend from it.
- Decided
- Feb 23, 2016
- Review
- 168 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K981251 (1998). 11 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 6 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 5 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 4 generations backK093419 Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10…Stryker Instruments, Instruments Div. · 2010
- 3 generations backK103807 Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation · 2011
- 2 generations backK113477 Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div. · 2012
- 1 generation backK123942 Stryker Ivas Balloon CatheterStryker Corporation · 2013 · Recalled
- This deviceK152557 Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. · 2016
- Descendant · cites it directly · 1 of its ownK172214 Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. · 2017
- Descendant · 2 generations on · 0 of its ownK200763 Osteo-site Vertebral BalloonIzi Medical · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −6 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −5 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −4 | K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500… | Stryker Instruments, Instruments Div. | 2010 | — |
| −3 | K103807 | Ivas 2-10MM (10 Guage) Ballon Catheter | Stryker Corporation | 2011 | — |
| −2 | K113477 | Ivas 20MM (10 Gauge) Balloon Catheter | Stryker Instruments, Instruments Div. | 2012 | — |
| −1 | K123942 | Stryker Ivas Balloon Catheter | Stryker Corporation | 2013 | 1 |
| 0 (this device) | K152557 | Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | 2016 | — |
| +1 | K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.R.L. | 2017 | — |
| +2 | K200763 | Osteo-site Vertebral Balloon | Izi Medical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | K130430 | Ivas 10MM and 15MM Balloon CatheterSummary page 5…code STRYKER IVAS BALLOON K130430, K123942, K113154, NDN, STRYKER… | 2013 |
| * | K123942 | Stryker Ivas Balloon CatheterSummary page 5…code STRYKER IVAS BALLOON K130430, K123942, K113154, NDN, STRYKER CATHE… | 2013 |
| * | K113154 | Ivas Balloon CatheterSummary page 5…code STRYKER IVAS BALLOON K130430, K123942, K113154, NDN, STRYKER CATHETER… | 2012 |
| * | K113477 | Ivas 20MM (10 Gauge) Balloon CatheterSummary page 5…942, K113154, NDN, STRYKER CATHETER K113477, K103807, K093419 HRX… | 2012 |
| * | K103807 | Ivas 2-10MM (10 Guage) Ballon CatheterSummary page 5…154, NDN, STRYKER CATHETER K113477, K103807, K093419 HRX… | 2011 |
| * | K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas…Summary page 5…NDN, STRYKER CATHETER K113477, K103807, K093419 HRX… | 2010 |
| * | K110998 | Affirm (TM) VCF SystemSummary page 5…NDN, ALGEA THERAPIES AFFIRM 15P K110998… | 2011 |
| † | K131820 | Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax… | 2013 |
| † | K103064 | Avamax Vertebral Balloon | 2011 |
| † | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | 2017 | 1 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K172214 (G-21 S.R.L., 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K130430.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutancous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, 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.
https://510kreport.com/device/K152557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152557: Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152557
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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