HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM

K050048 · Howmedica Osteonics Corp. · KTT · Mar 4, 2005 · Orthopedic

Device Facts

• Record ID: K050048
• Device Name: HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Mar 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Hoffmann® II Micro" External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires.

Device Story

External fixation system components; used to stabilize bone fractures or assist in reconstruction. System comprises metallic frame components; connects to commercially available fixation pins and Kirschner wires. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization for bone segments; allows for compression, distraction, or deformity correction. Benefits patients by providing rigid support for healing when internal fixation is contraindicated due to soft tissue status.

Clinical Evidence

No clinical data; substantial equivalence supported by mechanical performance testing.

Technological Characteristics

Metallic bone fixation components; modular external frame system. Designed for use with standard fixation pins and Kirschner wires. Materials and design consistent with existing Hoffmann II product line.

Indications for Use

Indicated for children and adults requiring stabilization of open/unstable fractures where soft tissue injury precludes internal fixation/casting. Specific uses: bone fracture fixation, osteotomy, arthrodesis, deformity correction, revision procedures, non-unions, delayed unions, and compression/distraction/lengthening.

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

• Hoffmann® II External Fixation System
• Hoffmann® II Compact™ External Fixation System
• Hoffmann® II Hybrid Frame System
• Monotube Triax™ External Fixation System

Submission Summary (Full Text)

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Hoffmann® II Micro Line Extension

MAR 4 - 2005

iC050048

510(k) Premarket Notification

# 510(k) Summary of Safety and Effectiveness for the Hoffmann® II Micro™ External Fixation System Line Extension

| Proprietary Name: | Hoffmann® II MicroTM External Fixation 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 and<br>Smooth or threaded metallic bone fixation fastener,<br>21 CFR §888.3040 |
| 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: | January 7, 2004 |

### Intended Use:

The Hoffmann® II Micro" External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires.

### Description:

This line extension is to add new components to the Hoffmann ® II Micro " External Fixation System. This component is an external fixation frame component and can be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® II Micro" External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax™ External Fixation System.

### Substantial Equivalence:

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 - 2005

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

Re: K050048 Trade/Device Name: Hoffmann® II Micro™ External Fixation System Regulation Numbers: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: KTT Dated: January 7, 2005 Received: January 10, 2005

Dear Ms. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased of the enactment date of the Medical Device Amendments, or to conimeres phor to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices that have been resuire approval of a premarket approval application (PMA). and Costletter Fer (110) and the device, subject to the general controls provisions of the Act. The I va may, merelore, maniev 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 If your device is blussined too works. Existing major regulations affecting your device can may be subject to back as a submitions, 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 r rease be actived that the revilation that your device complies with other requirements of the Act that 1 DA has intact a and regulations administered by other Federal agencies. You must of any I edetar statuates and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It i att 607), laooning (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

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manteang your as a couvalence of your device to a legally premarket noticate 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 If you ucate specific advice in 10-2 10-0120. Also, please note the regulation entitled, contact the Office of Comphane as (21 ) in the motification" (21CFR Part 807.97). You may obtain 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,

Mark A. Millhiser

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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## Indications for Use

510(k) Number (if known):

Device Name: Hoffmann® II Micro™ External Fixation System

Indications for Use:

The Hoffmann® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:

- Bone fracture fixation .
- . Ostcotomy
- . Arthrodesis
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
- Compression/distraction and lengthening t

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)

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

S10(k) Number: K050048

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