INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS

K051408 · Intelifuse, Inc. · JDR · Jun 29, 2005 · Orthopedic

Device Facts

• Record ID: K051408
• Device Name: INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS
• Applicant: Intelifuse, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For bone to bone and soft tissue to bone fixation.

Device Story

System comprises Nitinol bone staples and Warm System heating unit; used for bone-to-bone and soft-tissue-to-bone fixation. Staples feature parallel prongs during insertion; application of heat via Warm System electrodes causes inward prong deflection, providing compression and retention. Heating unit utilizes Joule effect to heat Nitinol staples to a maximum of 55°C within 5 seconds. Accessory pack includes resterilizable current source, drill bits, drill guide, impactor, forceps, and locator pin. Intended for use by clinicians in surgical settings. Provides mechanical fixation to stabilize bone fragments or soft tissue, facilitating healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitinol bone staples; heating via Joule effect using electrical current; internal circuitry limits temperature to 55°C within 5 seconds; accessory components include drill bits, guides, impactors, forceps, and locator pins; autoclavable heating wire electrodes.

Indications for Use

Indicated for hand and foot bone fragment fixation, osteotomy fixation, joint arthrodesis, proximal tibial metaphysis osteotomy fixation, and soft tissue to bone fixation (e.g., anterior cruciate reconstruction).

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Memograph Staple, Warm System (K993714)

Submission Summary (Full Text)

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K051408
May, 2005
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InteliFUSE, Inc. Traditional 510(k) Warm System with StimuLinks

JUN 2 9 2005

# TAB 4

# PREMARKET NOTIFICATION [510(K)] SUMMARY

- March, 2005

| Trade Name: | InteliFUSE, Inc. Warm System with StimuLinks |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Staple |
| Classification Name: | Staple, Bone Fixation (per 21 CFR section 888.3030) |
| Manufacturer's Name: | InteliFUSE, Inc.<br>5520 Willow Street<br>New Orleans, LA 70115<br>504-864-8111 |
| Corresponding Official: | Sharon Rockwell<br>Regulatory Affairs Consultant<br>5582 Chalon Road<br>Yorba Linda, CA 92886<br>Phone: [phone]<br>Fax: [phone] |
| Predicate Device(s): | Memograph Staple, Warm System, K993714, approved<br>February 25, 2000 (for hand and foot bone fragment,<br>osteotomy and fixation of soft tissue to bone) |
| Device Description: | The system consists of two and four prong staples for use in<br>various fixation techniques. The Nitinol staples have prongs<br>which are parallel during insertion. Application of heat from<br>the Warm System to the staple causes the prongs to deflect<br>inward. This inward deflection results in staple compression<br>and retention. The heat is applied through two electrodes in<br>an autoclavable heating wire. The electrodes are applied to<br>the back of the implanted staple to activate heating. |
| Intended Use: | For bone to bone and soft tissue to bone fixation. |
| Technological<br>Characteristics: | The Warm System uses the Joule effect of electrical current<br>in a conductor to increase the temperature of the Nitinol<br>staple. Internal circuitry controls the heating effect such that<br>a limiting temperature of 55°C is achieved in a maximum of<br>5 seconds. |

CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from IntelliFUSE, Inc.

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KOT.408 p²/2
May, 2005

InteliFUSE, Inc. Traditional 510(k) Warm System with StimuLinks

> An accessory pack is provided with the Warm System and includes the resterilizable current source, drill bits of different sizes for creating proper hole diameters, a drill guide for depth gauging, an impactor for tapping the staples in place, forceps, and a locator pin. The accessory pack components are all commercially available finished devices.

> The 2 prong StimuLink staples are available in wire thicknesses from 1.2 x 1.2 mm to 2mm x 3 mm, and in lengths and heights from 5 to 30 mm, including uneven prong heights. Four prong plates for multiaxial loads are available in ranges from 15 x 6 x 6 mm to 15 x 6 x 10 mm.

CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from InteliFUSE, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2005

Ms. Sharon Rockwell Regulatory Consultant InteliFUSE Incorporated 5520 Willow Street New Orleans, Louisiana 70115

Re: K051408 Trade/Device Name: InteliFUSE, Inc. Warm System with StimuLinks Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: May 27, 2005 Received: May 31, 2005

Dear Ms. Rockwell:

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 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.

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#### Page 2 - Ms. Sharon Rockwell

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 vours,

Stup Rhodes

am C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### TAB 3

## INDICATIONS FOR USE

Kos1408 510(k) Number:

Device Name: InteliFUSE, Inc. Warm System with StimuLinks

#### Indications for Use:

The InteliFUSE, Inc. Warm System with StimuLinks are used as a system for the following indications:

1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis

2) fixation of proximal tibial metaphysis osteotomy

3) fixation of soft tissue to bone such as anterior cruciate reconstruction.

X Prescription Use (per 21 CFR 801 Subpart D)

Or

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

#### (PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Of

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

3-1

CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from InteliFUSE, Inc.