STORM OPERATING KIT, MODEL 1-10-0

K061607 · Intelligent Orthopaedics, Ltd. · HTY · Jul 18, 2006 · Orthopedic

Device Facts

• Record ID: K061607
• Device Name: STORM OPERATING KIT, MODEL 1-10-0
• Applicant: Intelligent Orthopaedics, Ltd.
• Product Code: HTY · Orthopedic
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The STORM® Operating Kit is an external fixation accessory set used in conjunction with the STORM™ system for fracture reduction and fixation of the lower leg or distal femur. The kit includes two Kirschner wires (2mm diameter; 280mm and 400mm lengths), two 4.5mm self-threading bone screws, and a 3.2mm single-use drill bit. Components are provided non-sterile and require autoclave sterilization by the user before clinical application. The device is intended for use by orthopedic surgeons in a clinical setting to stabilize bone fractures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Components are manufactured from stainless steel. The kit includes Kirschner wires, self-threading bone screws, and a drill bit. The device is provided non-sterile and is designed for sterilization via autoclave.

Indications for Use

Indicated for the reduction and fixation of fractures of the lower leg or distal femur.

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

• Sterile Kirschner Wires and Steimann Pins (K960385)
• Non-Sterile Kirschner wires and Steinmann Pins (K983121)
• Synthes 3.5mm Cortex Screws (K043185)

Submission Summary (Full Text)

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K06/607 pg 1 of 2

AUL 1 8 2006

PO Box 2681 Stoke on Trent ST4 9BE

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

# E)510(k) Summary or 510(k) Statement

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

Date

26th May 2006

Contact person

Julio Gonzalez BSN medical Inc 5285 Carnegie Blvd Charlotte NC

| Proprietary Name | STORM® Operating Kit |
|----------------------------|----------------------------------------------------------------|
| Common Name | External Fixation Systems |
| Classification / Reference | Class II – 888.3040 Smooth or Threaded Bone Fixation fasteners |
| Product Code & Panel | HTY and HWC / Orthopedic |

## Device Description

The STORM®® 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 reduction and fixation of fractures of the lower leg or distal femur

## Technological characteristics

The STΦRM®® Operating Kit components are made from stainless and are presented non-sterile for sterilisation by autoclave.

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K061607 pg 2 of 2

# Substantial Equivalence

The components of the STΦRM™ Operating Kit are substantially equivalent to K960385 - Sterile Kirschner Wires and Steimann Pins, DePuy; K983121 - Non-Sterile Kirschner wires and Steinmann Pins, Syntec-Taichung Medical Instruments co Ltd and K043185- Synthes 3.5mm Cortex Screws, Synthes.

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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of four stylized human profiles facing to the right, with three lines above them that appear to represent movement or progress. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 18 2006

Intelligent Orthopaedics Limited % BSN medical Ltd. Mr. Neil McLachlan Global RA Manager Brierfield Mill Brierfield, Nelson Lanchashire BB9 5NJ

Re: K061607

Trade/Device Name: STΦRM™ Operating Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, HWC Dated: May 31, 2006 Received: June 9, 2006

Dear Mr. McLachlan:

We have reviewed your Section 510(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 such 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); good manufacturing practice requirements as set

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Page 2 – Mr. Neil McLachlan

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Karbarz Ruchur

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

Enclosure

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510(k) Number (if known):

Device Name:

Indications for Use:

The STORM™ Operating Kit is used in conjunction with the STORM™ 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)

Chabane Guellah

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K061667