# K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A

- Pathway: 510(k) (Traditional)
- Applicant: Kyphon, Inc.
- Decided: Jul 9, 2004 after 38 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981251 (1998). 3 ancestors in all.
73 later devices descend from it; 23 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032212: Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A, Kyphon, Inc. (2003) Summary page 4.
- K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A, Kyphon, Inc. (2001) Summary page 4.
- K981251: Kyphon Inflatable Bone Tamp, Kyphon, Inc. (1998) Summary page 4.

## Most influential descendants
- 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
- 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 (2010), 13 descendants of its own
- K053336: Staxx FX System (2006), 12 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
- Mar 23, 2011 · Not classified · Z-3175-2011: Device was shipped past the labeled expiration date.
- Feb 4, 2009 · Not classified · Z-1209-2009: Product not sterile: 10 units were released for distribution without undergoing sterilization process.

## Indications for use
KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.

Source page: https://510kreport.com/device/K041454
Methodology: https://510kreport.com/methodology