Unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality. For the XFIX® DFS® Rail System the indications are unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, acute or gradual correction and other bone conditions amendable to treatment by use of the external fixation modality.

Device Description

The Systems consist of external fixation components and implantable bone screws. The system is utilized in the following manner: bone screws are inserted through the patients skin and soft tissue into bone. The fixator frame of the system is attached the shanks of the bone screws.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Lower Extremity External Fixation) and the associated FDA clearance letter. It explicitly states that no clinical testing was performed as a basis for substantial equivalence.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be found in this document. The device's clearance was based on its similarity to legally marketed predicate devices, and non-clinical laboratory testing.

Summary

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JUL 30 2008

Innovation Meets Evolution ... EBI is now

510(k) Summary

SPINE
TRAUMA
BRACING
OSTEOBIOLOGICS

Preparation Date: April 28, 2008 Applicant/Sponsor: Biomet Trauma (previously EBI, L.P.) 100 Interpace Parkway Parsippany, NJ 07054 Establishment Registration Number: 1450662 Contact Person: Debra Bino Director of Regulatory Affairs Lower Extremity External Fixation- Expanded Indications Proprietary Name: Common Name: External fixation Classification Name: KTT- Single, multiple component metallic bone fixation appliances and accessories (888.3030)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

XFIX® DFS® System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, . K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433. K953406. K951357
XFIX® DFS® Rail System (Biomet Trauma)- K021031, K010437, K000083, K991941 .
XFIX® Vision (Biomet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 .
XFIX® OptiRom (Biomet Trauma)- K031093, K953406 ●
Dynafix Diaphyseal/Metaphyseal Correction Systems (Biomet Trauma)- K030372, K024248, . K021695, K001358, K953406
Hoffman® II Micro External Fixation System (Howmedica Osteonics, Inc.)- K052037, K050048 .

Device Description: The Systems consist of external fixation components and implantable bone screws. The system is utilized in the following manner: bone screws are inserted through the patients skin and soft tissue into bone. The fixator frame of the system is attached the shanks of the bone screws.

Indications for Use: Unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality. Additionally, the Rail System has the additional indication of acute or gradual correction.

Summary of Technologies: The technological characteristics (indications, materials, sizes, dimensions and packaging) are similar to or identical to that of the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was previously performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc. except for: Hoffman® II Micro External Fixation System is a trademark of Howmedica Osteonics, Inc.

100 Interpace Parkway Parsippany, NJ 07054 Toll Free: 800-526-2579 Phone: 973-299-9300 Main Fax: 973-299-1884

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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Trauma % Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

JUL 30 2008

Re: K081244 Trade/Device Name: Lower Extremity External Fixation Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 28, 2008 Received: May 1, 2008

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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

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Page 2 - Ms. Patricia Sandborn Beres

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.

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

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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Indications for Use

510(k) Number (if known): K081244

Device Name: Lower Extremity External Fixation - Expanded Indications

Indications For Use:

For the XFIX® DFS® Rail System the indications are unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, acute or gradual correction and other bone conditions amendable to treatment by use of the external fixation modality.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (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)

Mark A. Mulkeran

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

510(k) Number K081244

Page 1 of 1

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.