# K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A

- Pathway: 510(k) (Traditional)
- Applicant: Kyphon, Inc.
- Decided: Feb 14, 2001 after 19 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
78 later devices descend from it; 8 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A (2004), 73 descendants of its own
- K090211: Inflatable Bone Tamp (2009), 24 descendants of its own
- K093463: Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 (2010), 23 descendants of its own
- K103064: Avamax Vertebral Balloon (2011), 22 descendants of its own
- K032358: B-Twin Bone Expander System (B-Twin BE System) (2003), 16 descendants of its own

## Recalls of this device
- Apr 24, 2020 · Class II · Z-2389-2020: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required sur
- Apr 24, 2020 · Class II · Z-2391-2020: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required sur
- Apr 24, 2020 · Class II · Z-2390-2020: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required sur

Source page: https://510kreport.com/device/K010246
Methodology: https://510kreport.com/methodology