E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT

K043289 · Signal Medical Corp. · KTT · Feb 11, 2005 · Orthopedic

Device Facts

• Record ID: K043289
• Device Name: E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
• Applicant: Signal Medical Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Triple arthrodesis Isolated rearfoot arthrodesis Midfoot arthrodesis Comminuted trauma Diabetic Charcot reconstruction Most foot pathology not requiring fixation above the ankle

Device Story

E-Z Frame Surgical Boot stabilizes foot at or below ankle for post-surgical conditions; serves as alternative to Ilizarov or Sheppard Rings. System consists of boot stabilized on distal tibia, connected to distal ring around foot via carbon fiber rods. Foot stabilized to distal ring using Kirshner wires (K-Wires). Used in clinical/surgical settings by surgeons. Provides stable distal support for foot pathology; reduces need for multiple tibial surgical interventions required by traditional ring systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: 6061 Aluminum, ABS plastic, carbon fiber rods, FR10/11 laminate, ASTM F 17-4 Stainless Steel fixtures. Mechanical stabilization system using external boot and rod-to-ring fixation. Non-powered, manual surgical device.

Indications for Use

Indicated for patients requiring foot stabilization for triple arthrodesis, isolated rearfoot arthrodesis, midfoot arthrodesis, comminuted trauma, or diabetic Charcot reconstruction, and other foot pathologies not requiring fixation above the ankle.

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.

Reference Devices

• Kirshner Wires (K-Wire) (K960023)

Submission Summary (Full Text)

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K 043289

FEB 1 1 2005

3

## 510K SUMMARY OF SAFETY AND EFFECTIVENESS

The E-Z Frame Surgical Boot is manufactured of light weight stable materials to allow the surgeon to stabilize the foot at or below the ankle for post surgical conditions. Presently liizarov or Sheppard Rings are used for this purpose and require multiple avenues of surgical intervention in the tibia to stabilize the distal support ring. With the E-Z Frame system a boot is stabilized on the distal leg (tibia) and further stabilized to the distal ring about the foot with carbon fiber rods that are attached to the boot and ring respectfully. Light weight materials are employed using 6061 Aluminum, ABS plastic, carbon fiber rods, FR10/11 laminate and small ASTM F 17-4 Stainless Steel Fixtures. The foot is stabilized to the distal ring using Kirshner Wires (K-Wire) purchased from PROMEX of Indianapolis, IN under 510 K: K960023. The boot utilized to stabilize the device on the tibia is purchased and modified from Darco International of Virginia.

Indications for Use:

- 1. Triple arthrodesis
- 2. Isolated rearfoot arthrodesis
- 3. Midfoot arthrodesis
- 4. Comminuted trauma
- 5. Diabetic Charcot reconstruction
- 6. Most foot pathology not requiring fixation above the ankle

## Contact Information:

If further information is required, please contact Dr. Louis A. Serafin, Jr. at Signal Medical Corporation, 400 Pyramid Drive, Marysville, MI 48040. Phone [phone].

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Louis A Serafin, Jr., MD Signal Medical Corporation 400 Pyramid Dive Marysville, Florida

Re: K043289 Trade/Device Name: E Z Frame Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: January 31, 2005 Received: February 1, 2005

Dear Dr. Serafin:

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 - Louis A. Serafin, Jr., MD

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,

Mark N. Mikkelsen

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Page | of |
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5 10(K) Number (If known): _______________

E Z Frame Device Mame:

Indications For Use:

Triple arthrodesis Isolated rearfoot arthrodesis Midfoot arthrodesis Comminuted trauma Comminated a reconstruction Diabetic Charcot reconscraction
Most foot pathology not requiring fixation above the ankle

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| Concurrence of | |
|------------------------------------------------------------|---------|
| (ODE) | |
| Office of Device Evaluation | |
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K043289 |
| Prescription Use | X |
| Counter Use | |
| (Per 21 CFR 801.109) | |

OR Over-The-

(Optional Format