HOFFMANN II PELVIC CLAMP

K033145 · Howmedica Osteonics Corp. · LXT · Nov 5, 2003 · Orthopedic

Device Facts

• Record ID: K033145
• Device Name: HOFFMANN II PELVIC CLAMP
• Applicant: Howmedica Osteonics Corp.
• Product Code: LXT · Orthopedic
• Decision Date: Nov 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This submission describes an external fixation frame component for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System and Monotube Triax "External Fixation System and in conjunction with Apex® Pins. External fixation frames are 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.

Device Story

The Hoffmann® II Pelvic Clamp is an external fixation frame component used to stabilize pelvic fractures. It functions as a mechanical connector within the Hoffmann® and Monotube Triax™ external fixation systems, utilizing Apex® Pins to secure bone segments. The device is a modification of the Hoffmann® 30 Degree Pelvic Double Ball Joint. It is intended for use by surgeons in clinical settings to provide rigid stabilization when internal fixation or casting is contraindicated due to soft tissue damage. The device provides mechanical support to the fracture site, facilitating patient healing by maintaining alignment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: stainless steel and aluminum. Components: threaded locking bolts. Form factor: external fixation frame component. Principle: mechanical bone fixation/stabilization. No software or electronic components.

Indications for Use

Indicated for patients with open and/or unstable pelvic fractures where soft tissue injury precludes alternative treatments like 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.

Predicate Devices

• Hoffmann® 30 Degree Pelvic Double Ball Joint

Submission Summary (Full Text)

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NOV - 5 2003

# 510(k) Summary of Safety and Effectiveness for the Hoffmann® II Pelvic Clamp

033145
page 1 of 1

| Proprietary Name: | Hoffmann® II Pelvic Clamp |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Frame Component |
| Classification Name and Reference | Single/multiple component metallic bone fixation<br>appliances and accessories, 21 CFR §888.3030 |
| Device Product Code: | 87 LXT |
| For Information contact: | Vivian Kelly, Regulatory Affairs Consultant<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | September 29, 2003 |

#### Intended Use:

This submission describes an external fixation frame component for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System and Monotube Triax "External Fixation System and in conjunction with Apex® Pins. External fixation frames are 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.

## Description:

The subject Hoffmann® II Pelvic Clamp is used with the components in the Hoffmann® External Fixation System, Hoffmann® II External Fixation System and Monotube Triax™ External Fixation System to stabilize fractures of the pelvis using Apex® Pins. The Hoffmann® II Pelvic Clamp is a modification of the Hoffmann® 30 Degree Pelvic Double Ball Joint and is made from stainless steel and aluminum with threaded locking bolts.

## Substantial Equivalence:

Equivalency of this device is based on similarities in intended use, materials and design to the predicate device. Testing has been conducted on the Hoffmann® II Pelvic Clamp demonstrating substantial equivalence to the predicate 30 Degree Pelvic Double Ball Joint.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a stacked formation, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2003

Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K033145

Trade/Device Name: Hoffman® II Pelvic Clamp Regulation Number: 21 CFR 3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: LXT Dated: September 29, 2003 Received: September 30, 2003

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 - Ms. 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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

L. Mark N. Milberson

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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510(k) Number (if known): K 033145

Device Name: Hoffmann® II Pelvic Clamp

Indications For Use:

The Hoffmann® II Pelvic Clamp is an external fixation frame component 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Mark A. Millkerer

estorative

510(k) Number K033145