510(k) · Cleared
ClearedModified Winch 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
G-21 S.R.L. · NDN Cement, Bone, Vertebroplasty
Cleared on Aug 23, 2017 as substantially equivalent to K152557 (G21, S.R.L., 2016) after a 30-day review. Its family tree reaches back 8 generations to 1998. 1 later device descends from it.
- Decided
- Aug 23, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K981251 (1998). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK152557 Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. · 2016
- This deviceK172214 Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. · 2017
- Descendant · cites it directly · 0 of its ownK200763 Osteo-site Vertebral BalloonIzi Medical · 2020
Most influential descendants
Showing 1 of 1 · See all- K200763Osteo-site Vertebral BalloonIzi Medical · 2020 · cites it directly0descendants
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 | K152557 | Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | 2016 | — |
| 0 (this device) | K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.R.L. | 2017 | — |
| +1 | 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 |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152557 | Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersSummary page 5…K172214 Page 2 of 3 Product Codes HRX and NDN Predicate Device K152557, Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters Intended Use / Indications for Use Indications for Use: Th… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200763 | Osteo-site Vertebral Balloon | 2020 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K200763 (Izi Medical, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Modified 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 percutaneous 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 as stated in the FDA summary.
https://510kreport.com/device/K172214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172214: Modified 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/K172214
Report an extraction error
Are you the manufacturer?
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