HOFFMANN II MRI EXTERNAL FIXATION SYSTEM

K051306 · Howmedica Osteonics Corp. · LXT · Jun 17, 2005 · Orthopedic

Device Facts

• Record ID: K051306
• Device Name: HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: LXT · Orthopedic
• Decision Date: Jun 17, 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 fractures of the upper and lower extremities as well as the pelvic disruptions.

Device Story

Hoffmann® II MRI External Fixation System consists of metallic frame components designed for orthopedic stabilization of fractures; modifications allow safe use within Magnetic Resonance Imaging (MRI) environments. Device provides structural support for upper/lower extremity and pelvic fractures; used when soft tissue injury prevents standard treatments like casting or intramedullary rodding. Components integrate with existing Hoffmann and Monotube TRIAX systems and Apex pins. Healthcare providers (orthopedic surgeons) assemble the frame to stabilize bone segments; MRI compatibility allows patients to undergo imaging without removing the fixation hardware, provided specific safety conditions are met. Benefits include continuous fracture stabilization during diagnostic imaging.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing confirmed comparable properties to predicate; MRI environment testing established safety under predetermined conditions.

Technological Characteristics

Metallic bone fixation components; designed for MRI compatibility. System includes frames, rods, and pins. No software or electronic components.

Indications for Use

Indicated for stabilization of open and/or unstable fractures in patients where soft tissue injury precludes other treatments like IM rodding or casting. Used with Hoffmann, Hoffmann II, and Monotube TRIAX External Fixation Systems and Apex Pins.

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 External Fixation System (K051306)

Reference Devices

• Hoffmann® External Fixation System
• Monotube® TRIAX External Fixation System
• Apex® Pins

Submission Summary (Full Text)

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Hoffmann® II MRI External Fixation System

Image /page/0/Picture/1 description: The image shows the text "K051306" in a large, bold font. Below this, the text "Special 510(k) Premarket Notification" is printed in a smaller, regular font. The text appears to be part of a document or label, possibly related to a medical device or product requiring regulatory approval.

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

| Proprietary Name: | Hoffmann® II MRI External Fixation System |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Frame Components |
| Classification Name and Reference | Single/multiple component metallic bone<br>fixation appliances and accessories, 21 CFR<br>\$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: | May 18, 2005 |

### Description:

This Special 510(k) submission is intended to address modifications to the predicate Hoffmann This openal J ro(is) bachines to include components, which may be used safely for Magnetic Resonance Imaging (MRI).

### Intended Use:

The subject and predicate devices are external fixation frames intended to provide stabilization The subject and preatures of the upper and lower extremities as well as the pelvic disruptions.

### Indications for Use:

The Hoffmann® II MRI components are external fixation frame components for use with the The Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX * External Fixation System and in conjunction with Apex® Pins. oft is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

### Substantial Equivalence:

The subject Hoffmann® II MRI components share the same intended use, and basic design concents as that of the currently available Hoffmann® II 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 Magnetic Resonance Imaging under predetermined conditions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures, depicted as flowing, interconnected lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 2005

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

Re: K051306 Trade/Device Name: Hoffmann® II 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: LXT, KTT, JEC Dated: May 18, 1005 Received: May 19, 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 for access of 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 or unf 1 catal bather 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 orth 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. Vivian Kelly, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mationing of substantial equivalence of your device to a legally premiarked notification. "The I Driving of casion 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 If you desire specific advice for your don't and on on our and one of the regulation entitled, Colliact the Office of Complance at (210) = 16 = 16 = 18 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Miriam C. Provost

Miriam 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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### Indications for Use

510(k) Number (if known):

Device Name: Hoffmann® II MRI External Fixation Systems

Indications for Use:

The Hoffmann® II MRI components are external fixation frame components for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX" External Fixation System and in conjunction with Apex® Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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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Muriam C. Provost

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

510(k) Number K65136