# K141419: Zvplasty

- Pathway: 510(k) (Traditional)
- Applicant: Zavation, LLC
- Decided: Sep 12, 2014 after 106 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K981251 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131820: Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax Vertebral Balloon System, 11G, Care Fusion (2013) Summary page 5.
- 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, Stryker Instruments, Instruments Div. (2010) Summary page 5.

## Recalls of this device
- Mar 25, 2021 · Class II · Z-1739-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1722-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1734-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1741-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1747-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1729-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1736-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1707-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1703-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1740-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1748-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1712-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1746-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1706-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1702-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1713-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1728-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1735-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1724-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1704-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1733-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1743-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1700-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1726-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1709-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1738-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1708-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1732-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1721-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1737-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1725-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1705-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1711-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1723-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1710-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 25, 2021 · Class II · Z-1742-2021: Products distributed as sterile may not have been adequately sterilized

## Indications for use
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.

Source page: https://510kreport.com/device/K141419
Methodology: https://510kreport.com/methodology