MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM

K013449 · Disc-O-Tech Medical Technologies, Ltd. · HSB · Dec 19, 2001 · Orthopedic

Device Facts

• Record ID: K013449
• Device Name: MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
• Applicant: Disc-O-Tech Medical Technologies, Ltd.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fixion™ Interlocking Intramedullary Nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones.

Device Story

Fixion IL Nail is an expandable, non-slotted stainless steel intramedullary nail used for long bone fracture fixation. The system includes the nail implant, an instrument set, and a single-use manual plastic inflation pump. During surgery, the nail is inserted into the medullary canal; the surgeon uses the inflation device to fill the nail with sterile liquid, expanding its diameter to fit the canal under x-ray guidance. Interlocking screws may be used for additional stability. The device is intended for use by surgeons in an operating room setting. The expansion mechanism allows for a custom fit within the bone, potentially improving fracture stabilization compared to traditional rigid nails.

Clinical Evidence

Bench testing only. Mechanical performance was validated using 4-point bending tests per ASTM F1264-99. Materials meet ASTM F138 standards.

Technological Characteristics

Expandable non-slotted 316L stainless steel cylindrical tube (ASTM F138). Manual hydraulic expansion via plastic inflation pump. Interlocking screw fixation. Sterilized components. Mechanical performance tested per ASTM F1264-99.

Indications for Use

Indicated for fixation of diaphyseal fractures and short distal or proximal fragments in long bones.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Fixion Interlocking Intramedullary Nailing System (K002783)
• Fixion Intramedullary Nailing System (K990717, K003212, K003215, K010901)
• Unreamed Humeral Nail by Synthes (K933518)
• Unreamed Tibial Nail by Synthes (K914453)
• Unreamed Femoral Nail by Synthes (K923580)
• Ti Distal Femoral Nail by Synthes (K970733)
• True/Flex Upper Extremity IM Nail by Encore (K902264)

Submission Summary (Full Text)

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K0134/9

# 510(K) Summary

12-19-01

# Disc-O-Tech Medical Technologies, Ltd. Fixion Interlocking Intramedullary Nailing System

#### Company Name

Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzelia, 46728, Israel

#### Submitter's Name and Contact Person

Elad Magal Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzelia, 46728, Israel Tel: [phone] Fax: [phone]

### Date Prepared

October 2001

#### Trade/Proprietary Name

Fixion 1 1 Interlocking Intramedullary Nailing System (Fixion IL Nail)

## Classification Name

Intramedullary Fixation Rod 21 CFR & 888.3020 Class II

#### Predicate Devices

- 1. Fixion Interlocking Intramedullary Nailing System (Fixion IL Nail) by the company -K002783
- 2. Fixion Intramedullary Nailing System (Fixion IM Nail) by the company K990717, K003212, K003215, K010901
- 3. Unreamed Humeral Nail by Synthes K933518
- 4. Unreamed Tibial Nail by Synthes K914453
- 5. Unreamed Femoral Nail by Synthes K923580
- 6. Ti Distal Femoral Nail by Synthes K970733
- 7. True/Flex Upper Extremity IM Nail by Encore (Applied Osteo Systems, Inc.) -K902264

## Performance Standards

The following standards were used:

- 1. The Fixion IL Nail is manufactured from 316L Stainless Steel, which meets the requirements of ASTM F138 - Standard Specification for Wrought 18 Chromium - 14 Nickel - 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS
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S31673).

- 2. The Fixion IL Nailing System accessories incorporate surgical grade stainless steel and silicone.
- 3. The Fixion IL Nail is designed to meet the requirements of ASTM F565 Standard practice for Care and Handling of Orthopedic Implants and Instruments.
- 4. The 4 point bending mechanical testing was performed according to ASTM F1264-99 - Standard for Mechanical Performance Considerations for Intramedullary Fixation Devices.

## Intended Use

The Fixion™ Interlocking Intramedullary Nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones.

## System Description

The Fixion Interlocking Intramedullary Nailing System consist of the following main components:

1. The Nail Implant is an expandable non-slotted stainless steel cylindrical tube, with a cap protected, female threaded proximal end with holes for interlocking screws to lock the nail in the bone. The Nail Implant may also have both proximal and distal ends with holes for interlocking screws.

2. The Instrument Set consists of a few accessories used during insertion and removal (if required) of the Nail Implant.

3. The Inflation Device is a single-use, manual, plastic pump to be filled with sterile inflation liquid.

Once the nail is positioned within the medullary canal, rotation of the pump handle allows for nail diameter increase to its intended diameter under x-ray and controlled pressure. Interlocking screws may be used to lock the nail inside the bone.

## Substantial Equivalence

The Fixion IL Nail is substantially equivalent to the Fixion IL Nail currently cleared for marketing under 510(k) K002783.

The modified Fixion IL Nail has the following similarities to that which previously received 510(k) concurrence:

- > Has an equivalent intended use
- > Has basically the same operating principles
- > Incorporates similar design
- > Incorporates the same materials and processes
- > Is sterilized and packed, basically, in the same manner.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a flame, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050

DEC 1 9 2001

Mr. Elad Magal General Manager Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot Street Herzelia, 46728 Israel

Re: K013449

Trade/Device Name: Fixion Interlocking Intramedullary Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: October 15, 2001 Received: October 17, 2001

Dear Mr. Magal:

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 - Mr. Elad Magal

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 yours,

Celia M. Witten, Ph.D., M.D.

h

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(K) Number (if known): K013449

Device Name: Fixion™ Interlocking Intramedullary Nailing System (Fixion™ II. Nail)

Indication for Use: The Fixion™ Interlocking Intramedullary Nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1 (per 21 CFR 801.109)

OR

Over the Counter Use No

.

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

510(K) Number K013449

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