TRIMED X-FIX

K101375 · TriMed, Inc. · NDK · Sep 15, 2010 · Orthopedic

Device Facts

• Record ID: K101375
• Device Name: TRIMED X-FIX
• Applicant: TriMed, Inc.
• Product Code: NDK · Orthopedic
• Decision Date: Sep 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TriMed X-Fix System is a unilateral external fixation device. It is 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

Unilateral external fixation device; used for bone stabilization, limb lengthening, osteotomies, and arthrodesis. System comprises various sized components, including pin clamps, to accommodate diverse anatomies and injuries. Device couples to bone by securing pins into the frame. Used by surgeons in clinical settings to provide mechanical stability to bone segments. Benefits include stabilization of fractures and correction of bone deformities through external fixation.

Technological Characteristics

Unilateral external fixation system. Materials: aluminum, black carbon composite, and F-138 surgical grade stainless steel. Modular design with pin clamps for bone coupling.

Indications for Use

Indicated for patients requiring treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, and fracture fixation via external fixation modality.

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

• Avanta Orthopaedics External Fixator (K974911/K981716)

Submission Summary (Full Text)

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# ummary of Safety and Effectiveness TRIMED X-FIX SYSTEM

SEP 1 5 2010

| Submitted By: | TriMed, Inc.<br>25864 Tournament Road, Ste. A<br>Valencia, CA 91355<br>[phone] |
|-----------------------------|-------------------------------------------------------------------------------------------|
| Registration #: | 2031009 |
| Prepared By/Contact Person: | Kelli Anderson<br>Phone: [phone]<br>Fax: [phone] |
| Proprietary Name: | X-Fix System |
| Classification: | Class II: Smooth or Threaded<br>Metallic Bone Fixation Fastener<br>NDK - Section 888.3040 |

Summary Preparation Date:

September 13, 2010

#### I. Indications for Use:

The TriMed X-Fix System is a unilateral external fixation device. It is 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.

#### II. Device Description:

The X-Fix System is a unilateral external fixation device. It includes various size components to accommodate various anatomies and injuries. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use.

The X-Fix System is made of aluminum, black carbon composite and F-138 surgical grade stainless steel.

#### III. Substantial Equivalence:

The TriMed X-Fix System has been compared to the Avanta Orthopaedics External Fixator (K974911/K981716). The X-Fix is equivalent in dimensions, design and materials.

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

TriMed, Inc. % Ms. Kelli Anderson 25864 Tournament Road, Suite A Valencia, California 91355

SEP 1 5 2010

Re: K101375 Trade/Device Name: X-Fix System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: II Product Code: NDK Dated: August 11, 2010 Received: August 12, 2010

Dear Ms. Anderson

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

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Page 2 – Ms. Kelli Anderson

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.

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 enlitled, "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 vours.

Sincerely yours,

Mark A. Milliken

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

Enclosure

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## Indications for Use

510(k) Number (if known): _ Unknown KIDI375

### Device Name:___X-Fix

The TriMed X-Fix is a unilateral external fixation device. It is 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sonite
(Division Sign-Off) for nxn

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101375

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