# K061607: Storm Operating Kit, Model 1-10-0

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Orthopaedics, Ltd.
- Decided: Jul 18, 2006 after 39 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 1 generation back to K960385 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 2.
- K983121: Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220, Syntec Scientific Corp. (1998) Summary page 2.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 2.

## Most influential descendants
- K111001: Sterile Storm (R) Operating Kit (2011), 0 descendants of its own

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

Source page: https://510kreport.com/device/K061607
Methodology: https://510kreport.com/methodology