HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

K042019 · Howmedica Osteonics Corp. · KTT · Sep 24, 2004 · Orthopedic

Device Facts

• Record ID: K042019
• Device Name: HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Sep 24, 2004
• 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 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 in conjunction with commercially available Fixation Pins and/or Kirschner Wires.

Device Story

External fixation system providing skeletal stabilization; components include frames, fixation pins, and Kirschner wires. Used in clinical settings by surgeons to manage fractures, osteotomies, and deformities where soft tissue condition prevents internal fixation. Device functions as mechanical support structure; surgeon manually assembles frame components to stabilize bone segments. Output is rigid external construct maintaining fracture alignment; facilitates bone healing by preventing movement at injury site. Benefits patient by providing stable fixation in compromised soft tissue environments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation components; modular frame system; compatible with standard fixation pins and Kirschner wires. Mechanical assembly; no energy source or software.

Indications for Use

Indicated for children and adults requiring stabilization of open/unstable fractures, osteotomy, arthrodesis, deformity correction, revision procedures, non-unions, and delayed unions where soft tissue injury precludes internal fixation, IM rodding, or casting.

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® External Fixation System
• 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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## SEP 2 4 2004

K042019

### Modifications to the Hoffmann® II Micro

510(k) Premarket Notification

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

| Proprietary Name: | Hoffmann® II Micro™ 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: | July 26, 2004 |

#### Intended Use:

The Hoffmann ® II Micro" External Fixation System is intended 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 in conjunction with commercially available Fixation Pins and/or Kirschner Wires.

#### Description:

Description.
The new components are additions to the Hoffmann® II Micro™ External Fixation System. They are external fixation frame components intended to be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® 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. Testing has been conducted on the Hoffmann® II Micro™ new components 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 and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2004

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

Re: K042019 Ro+2019
Trade/Device Name: Hoffman® II Micro™ External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 26, 2004 Received: July 27, 2004

Dear Ms Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your 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 use suated in the encrease 1976, the enactment date of the Medical Device Amendments, or to conniner of the ride 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). and Cosmetter Fer (110) that the device, subject to the general controls provisions of the Act. The 1 ou may, there controls of the Act include requirements for annual registration, listing of general connologic would be mactice, 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 to such additional controls. Existing major regulations affecting your device can may or subject to back academations, 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 I Tours of actived 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 unly 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. Vivian Kelly

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis ictier with anow you to orgin mailoning of substantial equivalence of your device to a legally premits to the are in the Privating sification 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 spoonly at [phone]. Also, please note the regulation entitled, Contact the Office of Cremarket notification" (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/dsma/dsmamain.html

Sincerely vours,

Mark M. Wilkerson

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 .
- . Osteotomy
- Arthrodesis .
- . Correction of deformity
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .

Over-The-Counter Use Prescription Use X 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)

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

510(k) Number. K042019

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