# K151532: KYPHON ELEMENT Inflatable Bone Tamp

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jul 23, 2015 after 45 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.
No later device cites it as a predicate yet.
0 of 5 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 4.

## Indications for use
The KYPHON ELEMENT™ Inflatable Bone Tamp (IBT) 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 a balloon kyphoplasty procedure 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/K151532
Methodology: https://510kreport.com/methodology