JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE

K072212 · Smith & Nephew, Inc. · KTT · Mar 7, 2008 · Orthopedic

Device Facts

• Record ID: K072212
• Device Name: JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
• Applicant: Smith & Nephew, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Mar 7, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The devices described herein are intended to be used on adults or pediatric patients as reguired and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction: pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius. Jet-X® Bar System Clamps, Bars and Posts – MR Conditional are for single use only.

Device Story

Jet-X Bar System consists of clamps, bars, and posts used for external orthopedic fixation. Designed for fracture management, deformity correction, and limb lengthening. Components manufactured from non-magnetic materials (stainless steel, titanium, aluminum) to allow use in MR environment. Single-use devices provide rigidity and stability for bone stabilization. Operated by orthopedic surgeons in clinical or surgical settings. Output is mechanical stabilization of bone segments; assists clinical decision-making by maintaining alignment during healing process. Benefits patient by enabling fracture fixation and deformity correction while remaining compatible with MRI imaging.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

External fixation system components (clamps, bars, posts). Materials: stainless steel, titanium, aluminum. Non-magnetic construction for MR Conditional status. Mechanical fixation principle. Single-use. No software or electronic components.

Indications for Use

Indicated for adult and pediatric patients requiring fracture fixation (open/closed), management of post-traumatic joint contracture, fractures/disease causing joint contracture or loss of range of motion, fractures requiring distraction, pseudoarthrosis or non-union of long bones, limb lengthening via epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity/defects, joint arthrodesis, and management of comminuted intra-articular distal radius fractures.

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.

Submission Summary (Full Text)

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# K072Z12 (pg 1/1)

## 510(k) Summary of Safety and Effectiveness Jet-X® Bar System Clamps, Bars and Posts – MR Conditional

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 |
|-------------------------------------|---------------------------------------------------------------------------------------|
| Date: | August 8, 2007 |
| Contact Person: | David Henley<br>Regulatory Affairs Project Manager |
| Proprietary Name: | Jet-X® Bar System Clamps, Bars and Posts – MR<br>Conditional |
| Common Name: | External Fixation Accessories |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener,<br>21 CFR 888.3040, Class II |
| Device Product Code and Panel Code: | KTT / Orthopedics / 87 |

MAR - 7 2008#### Device Description:

External fixation devices, such as the Jet-X® Bar System Clamps, Bars and Posts – MR Conditional devices described herein, are specifically designed components to be used in the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Devices include Jet-X System Clamps, Bars, and Posts. The materials used in their manufacture are chosen to address a wide range of applications. These devices have been designed to allow for the appropriate amount of rigidity and stability. The devices described herein are made from non-magnetic materials and are intended for use in the MR environment.

#### Intended Use:

The devices described herein are intended to be used on adults or pediatric patients as reguired and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction: pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius. Jet-X® Bar System Clamps, Bars and Posts – MR Conditional are for single use only.

### Technological Characteristics:

The principle of operation of these devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation. These nonmagnetic MR Conditional devices utilize stainless steel, titanium, and aluminum materials and technological characteristics that are very similar when compared to the predicate devices.

#### Substantial Equivalence Information:

Documentation is provided in this premarket notification that demonstrates that Jet-X® Bar System Clamps, Bars and Posts - MR Conditional devices are substantially equivalent to other legally marketed devices.

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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 depiction of an eagle's head in profile, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Mr. David Henley Regulatory Affairs Project Manager 1450 Brooks Road Memphis, Tennessee 38116

MAR - 7 2008

Re: K072212 Trade/Device Name: Jet-X Bar System Clamps, Bars and Posts-MR Conditional Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: February 6, 2008 Received: February 7, 2008

Dear Mr. Henley:

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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Page 2 – Mr. David Henley

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 the reporting 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 toll-free number [phone] or [phone] or the 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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# K072212 (pg 1/1)

## Premarket Notification Indications for Use Statement

## Jet-X® Bar System Clamps, Bars and Posts – MR Conditional

### 510(k) Number (if known):

# Device Name: Jet-X® Bar System Clamps, Bars and Posts -- MR Conditional

### Indications for Use:

Jet-X Bar External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); posttraumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; infected fractures or non-unions; joint arthrodesis; and management of comminuted intraarticular fractures of the distal radius.

Jet-X Bar System Clamps, Bars and Posts – MR Conditional components are for single use only.

Prescription Use × (Per 21 CFR 801.109) OR

Over-the-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nat Re Ogl for mxm

and Neurological Devices

510(k) Number K072212