# K040939: Sky Bone Expander System (Sky System)

- Pathway: 510(k) (Special)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: May 12, 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: 7 generations back to K970097 (1997). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034037: Sky Bone Expander System, Disc-O-Tech Medical Technologies, Ltd. (2004) 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.

## Cited in the summary but kept off the family tree
- K033583: Progreat, Terumo Medical Corp. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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 cancellous bone in the spine, hand, tibia, radius and calcaneus.

Source page: https://510kreport.com/device/K040939
Methodology: https://510kreport.com/methodology