MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

K013772 · Howmedica Osteonics · LXT · Dec 3, 2001 · Orthopedic

Device Facts

• Record ID: K013772
• Device Name: MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
• Applicant: Howmedica Osteonics
• Product Code: LXT · Orthopedic
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hoffmann® II Micro External Fixation System is 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 may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

Device Story

Hoffmann® II Micro External Fixation System is a miniaturized line extension of the Hoffmann® II Compact™ External Fixation System. Device consists of metallic bone fixation components, including pins and connecting rods, designed for stabilization of open or unstable fractures. Used in clinical settings by surgeons to provide skeletal stabilization when soft tissue injury prevents internal fixation or casting. System functions as a mechanical frame; components are assembled to secure bone fragments. Benefits include providing rigid fixation in complex fracture cases where traditional methods are contraindicated. No software or electronic components involved.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical testing demonstrated comparable mechanical properties to the predicate device.

Technological Characteristics

Metallic bone fixation system; fabricated from stainless steel. Components include pins and connecting rods. Mechanical assembly; no energy source or software.

Indications for Use

Indicated for stabilization of open and/or unstable fractures in patients where soft tissue conditions preclude 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® II Compact™ External Fixation System (K013772)

Submission Summary (Full Text)

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# DEC 0 3 2001

Kol 3772
page 1 of 1

## Summary of Safety and Effectiveness Line Extension to the Hoffmann® II Compact™External Fixation System

### Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

Contact Person:

59 Route 17 Allendale, NJ 07401-1677

Howmedica Osteonics Corp

Karen Ariemma Regulatory Affairs Specialist

Date of Summary Preparation:

November 8, 2001

## Device Identification

| Proprietary Name: | Hoffmann® II Micro External Fixation System<br>(formerly the Hoffmann® II Compact™ External<br>Fixation System) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Frame Component |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation<br>fastener. 21 CFR §888.3040 |

This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Hoffmann® II Compact" External Fixation System. The subject device, named the Hoffmann® II Micro External Fixation System, is a line extension of the Hoffmann® II Compact External Fixation System. The predicate Hoffmann® II Compact External Fixation System is fabricated from stainless steel and aluminum. The subject Hoffmann® II Micro External Fixation System is fabricated from stainless steel. The Hoffmann® II Micro External Fixation System is a miniaturization of the Hoffmann® II Compact "External Fixation System. The miniaturization involves modifying the overall size of the components as well as reducing the size of the mating components (Apex® pins and connecting rods).

The subject Hoffmann® II Micro External Fixation System shares 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.

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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 stylized eagle or bird symbol with three curved lines representing its wings or body. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CEC 0 3 2001

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401

Re: K013772

Trade/Device Name: Hoffman® II Micro External Fixation System Regulation Number: 888.3040, 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JEC, LXT

Dated: November 8, 2001 Received: November 13, 2001

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains 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 11 Jour device to such additional controls. Existing major regulations affecting your device can may or bagges to been an arraderal 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 r reaso or hour 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 any I vith 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 Of It in the quality systems (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. Karen Ariemma

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

for Mark N Milliman

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 Ol 377 x

Device Name: Hoffmann® II Micro External Fixation System (line extension to the Hoffmann® II Compact™ External Fixation )

Indications For Use:

The Hoffmann® II Micro External Fixation System is 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 may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

KO134 42

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark N. Milliman

Division of General, Restorative and Neurological Devices

510(k) Number -