# K103231: Kyphon Inflation Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Spine, LLC
- Decided: Jan 24, 2011 after 84 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 K953522 (1996). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032840: Atrion Medical QL Inflation Device, Atrion Medical Products, Inc. (2004) Summary page 1.

## Most influential descendants
- K113742: KMC Kyphoplasty System (2012), 0 descendants of its own

## Indications for use
The Kyphon® Inflation Syringe is intended to be used to inflate and deflate inflatable devices (including Inflatable Bone Tamps) and to measure the pressure within the inflatable device during the procedure.

Source page: https://510kreport.com/device/K103231
Methodology: https://510kreport.com/methodology