510(k) · Cleared
Recalled · Class II · 2021Zvplasty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation, LLC · NDN Cement, Bone, Vertebroplasty
Cleared on Sep 12, 2014 as substantially equivalent to K131820 (Care Fusion, 2013) and 1 other predicate after a 106-day review. Its family tree reaches back 6 generations to 1998. It has been recalled 36 times.
- Decided
- Sep 12, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- NDN
- Recalls
- 36
- Predicates
- 2
Its longest line of descent runs back 6 generations to K981251 (1998). 11 ancestors in all. No later device cites it as a predicate yet.
- 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 backK090211 Inflatable Bone TampCardinal Health, Inc. · 2009
- 2 generations backK093463 Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010
- 1 generation backK131820 Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon…Care Fusion · 2013
- This deviceK141419 ZvplastyZavation, LLC · 2014
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 | K090211 | Inflatable Bone Tamp | Cardinal Health, Inc. | 2009 | — |
| −2 | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | Care Fusion | 2010 | — |
| −1 | K131820 | Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G… | Care Fusion | 2013 | — |
| 0 (this device) | K141419 | Zvplasty | Zavation, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K131820 | Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax…Summary page 5…MMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Predicate Device: CareFusion, AVAmax Vertebral Balloon (K131820) Stryker, iVas 2-10 Balloon Catheter (K093419) Technological Characteristics: The Zavation ZVplasty system possesses the same te… | 2013 |
| * | K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas…Summary page 5…cutaneous vertebral augmentation procedures, such as kyphoplasty. Predicate Device: CareFusion, AVAmax Vertebral Balloon (K131820) Stryker, iVas 2-10 Balloon Catheter (K093419) Technological Characteristics: The Zavation ZVplasty system possesses the same technological characteristics as the predicate.… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2021 | Class II | Z-1739-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1722-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1734-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1741-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1747-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1729-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1736-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1707-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1703-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1740-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1748-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1712-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1746-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1706-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1702-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1713-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1728-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1735-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1724-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1704-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1733-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1743-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1700-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1726-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1709-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1738-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1708-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1732-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1721-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1737-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1725-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1705-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1711-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1723-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1710-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
| Mar 25, 2021 | Class II | Z-1742-2021 | Vendor change control | Products distributed as sterile may not have been adequately sterilized |
The 5 latest of 36 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K131820.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Zavation ZVplasty (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 as stated in the FDA summary.
https://510kreport.com/device/K141419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141419: Zvplasty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141419
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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