# K111001: Sterile Storm (R) Operating Kit

- Pathway: 510(k) (Special)
- Applicant: Intelligent Orthopaedics, Ltd.
- Decided: May 17, 2011 after 36 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960385 (1996). 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)
- K061607: Storm Operating Kit, Model 1-10-0, Intelligent Orthopaedics, Ltd. (2006) Summary page 1.

## Indications for use
The ST4DRM™ Operating Kit is used in conjunction with the ST4DRM™ in the reduction and fixation of fractures of the lower leg or distal femur.

Source page: https://510kreport.com/device/K111001
Methodology: https://510kreport.com/methodology