HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM

K053038 · Howmedica Osteonics Corp. · KTT · Nov 22, 2005 · Orthopedic

Device Facts

• Record ID: K053038
• Device Name: HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject and predicate devices are external fixation frames intended to provide stabilization of open and/or unstable fractures of the upper and lower extremities.

Device Story

Hoffmann II Compact MRI External Fixation System consists of metallic bone fixation components; designed for stabilization of open/unstable fractures; modified to be MRI conditional. System used by surgeons in clinical settings to provide skeletal stabilization when internal fixation is contraindicated due to soft tissue injury. Device provides mechanical support to bone segments; MRI conditional status allows patients to undergo MRI diagnostic procedures under predetermined conditions. Benefits include continued fracture stabilization during necessary diagnostic imaging.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated comparable properties to predicate; testing in Magnetic Resonance Environment established MRI conditional safety under predetermined conditions.

Technological Characteristics

Metallic bone fixation components; external fixation frame; MRI conditional design. No specific materials or ASTM standards provided in text.

Indications for Use

Indicated for stabilization of open and/or unstable fractures of upper and lower extremities where soft tissue injury precludes other treatments like IM rodding or casting. Used with Hoffmann External Fixation System Half Pins, Transfixing Pins, and Hoffmann II External Fixation System components.

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

• Hoffmann II Compact External Fixation System (K053038)

Submission Summary (Full Text)

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NOV 2 2 2005

# KOS3038 (pg 10f

# Summary of Safety and Effectiveness Hoffmann® II Compact™ MRI External Fixation System

| Proprietary Name: | Hoffmann® II Compact™ MRI External Fixation<br>System |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Frame Components |
| Classification Name and Reference | Single/multiple component metallic bone fixation<br>appliances and accessories, 21 CFR §888.3030 |
| Device Product Code: | 87 KTT, 87 LXT & 87 JEC |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | October 25, 2005 |

# Description:

This Special 510(k) submission is intended to address modifications to the predicate Hoffmann® II Compact "External Fixation Systems to include MRI conditional components for use in Magnetic Resonance Imaging (MRI) procedures under predetermined conditions

# Intended Use:

The subject and predicate devices are external fixation frames intended to provide stabilization of open and/or unstable fractures of the upper and lower extremities.

# Indications for Use:

The Hoffmann® II Compact™ MRI components are intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, and other means of internal fixation.

# Substantial Equivalence:

The subject Hoffmann® II Compact™MRI components share the same intended use, and basic design concepts as that of the currently available Hoffmann® II Compact™ External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and testing in a Magnetic Resonance Environment established that the components could be safely used in MRI diagnostic procedures under predetermined conditions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2005

Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K053038 Trade/Device Name: Hoffman® II Compact™ MRI External Fixation Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, JEC, LXT Dated: October 25, 2005 Received: October 27, 2005

Dear Ms. Kelly:

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 - Vivian Kelly

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. Melkerson

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

Enclosure

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# Indications for Use

510(k) Number (if known): \५०५३०३८

Device Name: Hoffmann® II Compact™ MRI External Fixation Systems

Indications for Use:

The Hoffmann® II Compact™ MRI components are intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, and other means of internal fixation.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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signature

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

510(k) Numberko 53038

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