# K040612: Sky Bone Expander System (Sky System)

- Pathway: 510(k) (Traditional)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Jun 17, 2004 after 101 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: 7 generations back to K970097 (1997). 29 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 43 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.
- K034037: Sky Bone Expander System, Disc-O-Tech Medical Technologies, Ltd. (2004) Summary page 2.

## Most influential descendants
- 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
- K202393: SpineJack Expansion Kit (2020), 3 descendants of its own

## Indications for use
The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancelious bone in the spine, hand, tibia, radius and calcaneus. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cements that are legally marketed for use in vertebroplasty or kyphoplasty procedures.

Source page: https://510kreport.com/device/K040612
Methodology: https://510kreport.com/methodology