# K034037: Sky Bone Expander System

- Pathway: 510(k) (Special)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Jan 28, 2004 after 30 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: 6 generations back to K970097 (1997). 28 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032358: B-Twin Bone Expander System (B-Twin BE System), Disc-O-Tech Medical Technologies, Ltd. (2003) Summary page 2.
- K981251: Kyphon Inflatable Bone Tamp, Kyphon, Inc. (1998) Summary page 2.
- K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A, Kyphon, Inc. (2001) Summary page 2.
- K032212: Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A, Kyphon, Inc. (2003) Summary page 2.

## Most influential descendants
- K040612: Sky Bone Expander System (Sky System) (2004), 13 descendants of its own
- K053336: Staxx FX System (2006), 12 descendants of its own
- K063606: Modification to Staxx FX System (2007), 11 descendants of its own
- K132817: Kiva VCF Treatment System (2014), 9 descendants of its own
- K181262: SpineJack Expansion Kit (2018), 4 descendants of its own

## Indications for use
The SKy System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

Source page: https://510kreport.com/device/K034037
Methodology: https://510kreport.com/methodology