EXTERNAL FIXATOR SYSTEM

K122208 · Christopher D. Endara · NDK · Dec 20, 2012 · Orthopedic

Device Facts

• Record ID: K122208
• Device Name: EXTERNAL FIXATOR SYSTEM
• Applicant: Christopher D. Endara
• Product Code: NDK · Orthopedic
• Decision Date: Dec 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The external fixation system is a device intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Device Story

External fixation system for orthopedic bone stabilization; includes clamps, carbon fiber rods (8.0mm or 11.0mm), and Schanz screws (4.0mm to 6.0mm diameters). Components coupled to bone to create rigid frame; used for limb lengthening, osteotomies, arthrodesis, and fracture fixation. Operated by surgeons in clinical settings. System provides mechanical stability to bone segments; facilitates healing of bone conditions. Distributed non-sterile; requires end-user steam sterilization.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

System components include carbon fiber rods and metallic Schanz screws. Clamps facilitate coupling of rods and screws. Distributed non-sterile; sterilized by end-user via steam sterilization per AAMI/ANSI/ISO 11737 guidelines to achieve SAL 10^-6.

Indications for Use

Indicated for patients requiring treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation, and other conditions amenable to external fixation.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• K101375
• K973017
• K971755
• K030390
• K040258

Submission Summary (Full Text)

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### 510(k) Summary

## DEC 2 0 2012

| Company Name: | Christopher D. Endara<br>11767 S. Dixie Highway, #313<br>Pinecrest, Florida 33156 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Christopher D. Endara<br>11767 S. Dixie Highway, #313<br>Pinecrest, Florida 33156<br>Phone [phone] |
| Date Prepared: | October 20, 2012 |
| Trade Name: | External Fixation System |
| Common Name: | External Fixation |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener |
| Product Code: | NDK |
| Predicate Devices: | K101375, K973017, K971755, K030390, and K040258 |
| Device Description: | The external fixation system includes various size components<br>to accommodate various anatomies and injuries. The clamps<br>enable the frame to be coupled to bone by securing the rods<br>and Schanz Screws for the intended use. |
| | Components designed for this system are the medium clamp to<br>accept the 8.0mm carbon fiber rod (100mm to 500mm length)<br>and Schanz Screws (4.0mm diameter x 125mm length and<br>5.0mm diameter x 150mm to 200mm lengths), and the large<br>clamp to accept the 11.0mm carbon fiber rod (100mm to<br>500mm length) and Schanz Screws (4.0mm diameter x 125mm<br>length, 5.0mm diameter x 150mm length to 200mm lengths,<br>and 6.0mm diameter x 225mm to 300mm lengths). |
| Intended Use: | The external fixation system is a device intended to be used in<br>the treatment of bone conditions including limb lengthening,<br>osteotomies, arthrodesis, fracture fixation, and other bone<br>conditions amenable to treatment by use of the external<br>fixation modality. |

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Substantial Equivalence: The external fixation system has the same intended use, materials, and same technological characteristics as the predicate devices. Based on the information submitted, it is determined that the external fixation system is substantially equivalent to the currently marketed predicate devices.

The external fixation system is substantially equivalent to the Technological Characteristics predicate devices with respect to the design, function, and Comparison: material.

Sterilization The external fixator system will be distributed non-sterile. The Information: devices are sterilized by the end user per the AAMI Guidelines "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and ANSI/AAMI/ISO 11737 guidelines to achieve the Sterility Assurance Level (SAL) of 105.

Conclusion: There are no significant differences between the external fixation system and the other devices as listed in the Substantially Equivalent Devices. The external fixation system and the predicate devices have similar design attributes, material, and intended use thus is considered substantially equivalent.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### Letter dated: December 20, 2012

Christopher D. Endara President 11767 South Dixie Highway, #313 Pinecrest, Florida 33156

Re: K12208

Trade/Device Name: External Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: NDK Dated: November 15, 2012 Received: November 28, 2012

Dear Mr. Endara:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Christopher D. Endara

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

### 510(k) Number: K122208

Device Name: External Fixation System

Indications for Use: The external fixation system is a device intended to be used in treatment of bone conditions including limb lengthening, osteotomies, the arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Prescription Use __ × (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)

Krishna Asundi

Division of Orthopedic Devices

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