# K123771: Kyphon Express II Inflatable Bone Tamps

- Pathway: 510(k) (Special)
- Applicant: Medtronic
- Decided: Dec 21, 2012 after 14 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: 4 generations back to K981251 (1998). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101864: Kyphon Xpander II Inflatable Bone Tamp, Medtronic (2010) Summary page 2.

## Most influential descendants
- 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

## Indications for use
The KYPHON Xpander II Inflatable Bone Tamps and Kyphon® Express II Inflatable Bone Tamps are 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/K123771
Methodology: https://510kreport.com/methodology