METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS

K071679 · Disc-O-Tech Medical Technologies, Ltd. · HSB · Dec 17, 2007 · Orthopedic

Device Facts

• Record ID: K071679
• Device Name: METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
• Applicant: Disc-O-Tech Medical Technologies, Ltd.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Meta-Fix Intramedullary Nailing System is intended for use in the fixation of 1. long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones. The Fixion FA (RU-Fix) Intramedullary Nailing System is intended for use in the 2. fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.

Device Story

Expandable stainless steel intramedullary nail system; used for fixation of long bone fractures (metacarpal, metatarsal, radius, ulna). System comprises cylindrical nail (supplied in reduced diameter), insertion handle, and pump. Surgeon inserts nail into medullary canal; pump expands nail to provide fixation against bone walls. Eliminates need for interlocking screws. Used in clinical/surgical settings. Provides stable fracture fixation; facilitates bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design similarity to predicate devices.

Technological Characteristics

Expandable stainless steel cylindrical rod; non-interlocking design. Includes insertion handle and pump for expansion. Mechanical fixation principle via radial expansion against medullary canal walls.

Indications for Use

Indicated for fixation of long bone fractures, specifically diaphyseal fractures of the metacarpal, metatarsal, radius, and ulna 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 Intramedullary Nailing System (K990717, K010901)
• Fixion PF Intramedullary Nailing System (K010988, K012967, K023437)
• Titanium Elastic Nail System by Synthes (K042135)
• True/Flex Nail by Encore (K902264, K913949)

Submission Summary (Full Text)

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K071679 pg 1 of 3

#### 510(K) Summary

## Disc-O-Tech Medical Technologies Ltd. Meta-Fix - Metacarpal/Metatarsal Fixion® Intramedullary Nailing System Fixion® FA - Radius/Ulna Fixion® Intramedullary Nailing System

#### Submitter Name

Disc-O-Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel

DEC 17 2007

#### Contact Person

Yael Rubin Disc-O-Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel Tel: [phone], Fax: [phone]

#### Date Prepared

November 2007

#### Trade/Proprietary Name

- Metacarpal/Metatarsal Intramedullary Nailing System (Meta-Fix 1. Fixion Intramedullary Nailing System)
- Radius/Ulna Fixion Intramedullary Nailing System (Fixion FA Intramedullary 2. Nailing System, or - RU-Fix Intramedullary Nailing System)

#### Common Name

Intramedullary Fixation Rod

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#### Classification Name

Intramedullary Fixation Rod Class 11: 21 CFR §888.3020

#### Product Code

HSB

#### Predicate Devices

- √ Fixion Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (K990717, K010901)
KU71679

2.11

- √ Fixion PF Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (K010988, K012967, K023437)
- V Titanium Elastic Nail System by Synthes (K042135)
- V True/Flex Nail by Encore (K902264, K913949)

#### Intended Use

- The Meta-Fix Intramedullary Nailing System is intended for use in the fixation of 1. long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones.
- The Fixion FA (RU-Fix) Intramedullary Nailing System is intended for use in the 2. fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.

#### System Description

:

The Meta-Fix and Fixion FA Intramedullary Nailing Systems consist of the following main components:

The nail is an expandable, stainless steel, cylindrical rod without interlocking holes. It is supplied in a reduced diameter.

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# KU 11674

The instrumentation includes, mainly, an insertion handle and a pump. The insertion handle is connected to the nail proximal end; the instrumentation is used for nail insertion and expansion.

In addition the system consists of accessory tools.

#### Substantial Equivalence

In general, the Meta-Fix and Fixion FA Intramedullary Nailing Systems intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, line-art style, and the text is in a sans-serif font. The seal is black and white.

DEC 1 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disc-O-Tech Medical Technologies, Ltd. % Mr. Yael Rubin 11 Ha'Hoshlim Street Herzliya 46724 Israel

Re: K071679

Trade/Device Name: MetaFix and Fixion FA Intramedullary Nailing Systems Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 2, 2007 Received: December 7, 2007

Dear Mr. Rubin:

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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Pagc 2 - Mr. Yael Rubin

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark N. Mulkerson

Mark N. Melkerson 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): K071679

#### Device Name:

- 1. Metacarpal/Metatarsal Fixion Intramedullary Nailing System (MetaFix Intramedullary Nailing System)
- 2. Radius/Ulna Fixion Intramedullary Nailing System (Fixion FA Intramedullary Nailing System)

#### Indication for Use:

- 1. The MetaFix Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones.
- 2. The Fixion FA Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.

| Prescription Use | <div style="display:inline-block; vertical-align:middle;">✓</div> |
|-----------------------------|-------------------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (Part 21 CFR 801 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brechum

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

**510(k) Number** K071679