# K101864: Kyphon Xpander II Inflatable Bone Tamp

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: Oct 14, 2010 after 104 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981251 (1998). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 1.

## Most influential descendants
- K123771: Kyphon Express II Inflatable Bone Tamps (2012), 3 descendants of its own
- K172116: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (2018), 1 descendant of its own
- K191596: Arcadia Balloon Catheter (2019), 0 descendants of its own
- K181752: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (2018), 0 descendants of its own
- K122503: Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon Inflatable Bone Tamp-15 MM Balloon Parallax Balloon (2013), 0 descendants of its own

## Indications for use
The KYPHON Xpander TM II Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures) hand, tibia, radius and calcaneus.

Source page: https://510kreport.com/device/K101864
Methodology: https://510kreport.com/methodology