SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE

K043039 · Synthes (Usa) · KTT · Jan 18, 2005 · Orthopedic

Device Facts

• Record ID: K043039
• Device Name: SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Jan 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Synthes External Fixation Devices - MR Safe are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.

Device Story

Synthes External Fixation Component Line Extension consists of pin clamps with outrigger posts and curved carbon fiber rods. These components form an external fixation frame for treating stable and unstable fractures. All frame elements are constructed from non-magnetic materials, rendering the system MR Safe for use in the MR environment. The device is used by surgeons in clinical settings to stabilize bone segments, assist in reduction, or facilitate limb lengthening. By providing a rigid, non-magnetic construct, the device allows patients to undergo MRI procedures without the risks associated with traditional metallic fixation hardware.

Clinical Evidence

Bench testing only.

Technological Characteristics

External fixation components including pin clamps, outrigger posts, and curved carbon fiber rods. Constructed from non-magnetic materials to ensure MR safety. Mechanical fixation system; no energy source or software components.

Indications for Use

Indicated for pediatric and adult patients requiring external fixation for long bone and pelvic fractures. Specific applications include stabilization of soft tissues and fractures; polytrauma; vertically stable pelvic fractures or as an adjunct for vertically unstable pelvic fractures; arthrodeses and osteotomies with soft tissue problems; total joint failures; neutralization of fractures stabilized with limited internal fixation; non-unions/septic non-unions; intra-operative reduction/stabilization; and unilateral rectilinear bone segment transport or leg lengthening.

Regulatory Classification

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.

Predicate Devices

• Synthes Reprocessed External Fixation Devices
• Hoffmann II External Fixation System (Stryker)
• EBI XFIX Vision Fixation System

Submission Summary (Full Text)

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11043039

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| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
| | Device Name: | Synthes (USA) External Fixation Component Line Extension - MR Safe |
| | Classification: | Class II, §888.3030 - Single/multiple component bone fixation<br>appliances and accessories |
| | Predicate Device: | Synthes Reprocessed External Fixation Devices<br>Hoffmann II External Fixation System (Stryker)<br>EBI XFIX Vision Fixation System |
| | Device Description: | Synthes External Fixation Systems, MR Safe are a system of<br>components that form a construct intended to treat stable and<br>unstable fractures. All frame elements are made from non-<br>magnetic materials and are intended for use in the MR<br>environment. This line extension consists of Synthes Pin Clamps<br>with Outrigger Posts and additional Curved Carbon Fiber Rods.<br>These components are also intended for use in the MR<br>environment. |
| | Intended Use: | Synthes External Fixation Devices - MR Safe are intended for use<br>in the construction of an external fixation frame for treatment of<br>various fracture types that require external fixation |
| | Substantial<br>Equivalence: | Documentation is provided which demonstrates that the Synthes<br>(USA) External Fixation Component Line Extension - MR Safe is<br>substantially equivalent to other legally marketed devices.<br><br>The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Federal Food, Drug and Cosmetic Act, as amended<br>and as applied under 21CFR 807, Subpart E under which a device<br>can be marketed without premarket approval or reclassification. A<br>determination of substantial equivalency under this notification is<br>not intended to have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence<br>herein shall be construed as an admission against interest under the<br>US Patent Laws or their application by the courts. |

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

JAN 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathy Anderson Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K043039

Trade/Device Name: Synthes (USA) External Fixation Component Line Extension – MR Safe Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 2, 2004 Received: November 4, 2004

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 for ass batted in the 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 r ou may) ators, orovisions of the Act include requirements for annual registration, listing of general volurols proving 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 or any I vathar sthates 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 - Ms. Kathy Anderson

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

O. Mark A. Mullerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Mark N. Mlbess

and Neurological Devices

Indications for Use

2.0

**510(k) Number** K043039

510(k) Number (if known):

Synthes (USA) External Fixation Component Line Extension - MR Safe Device Name:

Indications for Use:

Synthes External Fixation Devices - MR Safe are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.

## LARGE

Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:

- Stabilization of soft tissues and fractures .
- Poyltrauma/multiple orthopedic trauma .
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic . fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints .
- Neutralization of fractures stabilized with limited internal fixation .
- Non-unions/septic non-unions .
- Intra-operative reductions/stabilization tool to assist with indirect reduction .
- Unilateral rectilinear bone segment transport or leg lengthening .

## MEDIUM

Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.

X Prescription Use (Per 21 CFR 801.109)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)