STERILE STORM (R) OPERATING KIT

K111001 · Intelligent Orthopaedics, Ltd. · HWC · May 17, 2011 · Orthopedic

Device Facts

• Record ID: K111001
• Device Name: STERILE STORM (R) OPERATING KIT
• Applicant: Intelligent Orthopaedics, Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: May 17, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STΦRM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur.

Device Story

STORM™ Operating Kit comprises two Kirschner wires (2mm diameter; 280mm and 400mm lengths), two 4.5mm self-threading bone screws, and one 3.2mm single-use drill bit. Used in clinical settings by orthopedic surgeons in conjunction with the STORM™ system for fracture reduction and fixation of the lower leg or distal femur. Components are provided sterile to facilitate surgical procedures. The kit provides the necessary mechanical fasteners and preparation tools to stabilize bone fractures, aiding in patient recovery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and mechanical performance testing.

Technological Characteristics

Components manufactured from stainless steel. Kit includes Kirschner wires, self-threading bone screws, and a drill bit. Provided sterile. Mechanical fixation system.

Indications for Use

Indicated for the reduction and fixation of fractures of the lower leg or distal femur in patients requiring orthopedic surgical intervention.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• STORM™ Operating Kit (K061607)

Submission Summary (Full Text)

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K 111001 (1/2)

MAY 17 2011

FDA CDRH DMC

APR 11 2011

Received

PO Box 2681 Stoke on Trent ST4 9BE

T: [phone] F: [phone] www.intelligent-orthopaedics.co.uk

# E) 510(k) Summary

Submitted by

Peter Ogrodnik Managing Director Intelligent Orthopaedics Limited Building 103 Campbell Road Stoke on Trent Staffordshire ST4 4DE United Kingdom

Date

25th March 2011

Contact person: Peter Ogrodnik

Sterile STORM®® Operating Kit

Proprietary Name Common Name Classification / Reference

External Fixation Systems Class II - 888.3040 Smooth or Threaded Bone Fixation fasteners HTY and HWC / Orthopedic

Product Code & Panel

Device Description

The STΦRM™ Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.

## Intended Use

The STORM™ Operating Kit is used in conjunction with the STΦRM™ in the reductic and fixation of fractures of the lower leg or distal femur

## Technological characteristics

The STΦRM™ Operating Kit components are made from stainless steel and are presented sterile.

## Substantial Equivalence

The components of the Sterile STORM™ Operating Kit are substantially equivalent to K061607 STORM™ Operating Kit

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Equivalency is based on similarities in intended use, materials and design to the predicate devices and the mechanical performance demonstrating substantial equivalence to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Room -WO66-G609 Silver Spring, MD 20993-0002

Intelligent Orthopaedics Limited % Staffordshire University Mr. Peter Ogrodnik Managing Director Business Village, Leek Road Stoke On Trent, Staffordshire United Kingdom ST4 2AR

MAY 17 2011

Re: K111001

Trade/Device Name: STORMTM Operating Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: March 25, 2011 Received: April 22, 2011

Dear Mr. Ogrodnik:

We have reviewed your Section 51.0(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Peter Ogrodnik

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aig B. R. h
for

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): {{{| | 0 0

Device Name:

Indications for Use:

The STΦRM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melkerson

(Division Sign-Off) (Division of Surgical, Orthopedic,
Division of Surgical, Orthopedic, Division Restorative Devices

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510(k) Number K111001