SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE

K040258 · Synthes (Usa) · KTT · Mar 23, 2004 · Orthopedic

Device Facts

• Record ID: K040258
• Device Name: SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Mar 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Intended for use in the construction of an external fixator frame for the treatment of pediatric and adult fractures.

Device Story

Synthes Medium External Fixation System - MR Safe is a modular orthopedic construct for treating stable and unstable fractures. System components include multi-pin clamps (four/six position), combination clamps, open adjustable clamps, dynamization clips, and rod attachments. The system utilizes 8.0 mm carbon fiber rods and 4.0-5.0 mm Schanz screws. All frame elements are constructed from non-magnetic materials to ensure safety within the MR environment. The device is used by surgeons to stabilize bone fractures, allowing for dynamization during the healing process and double stacking of the frame. It provides mechanical support to facilitate bone healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed from non-magnetic stainless steel, titanium alloy, and cobalt alloy. Modular frame system including clamps, rods, and screws. Designed for MR environment compatibility. No software or electronic components.

Indications for Use

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

Predicate Devices

• Synthes Medium External Fixation System

Submission Summary (Full Text)

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040a258

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| 3.0 | 510(k) Summary | Page 1 of 1 |
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| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Medium External Fixation System - MR Safe |
| Classification: | Class II, 21 CFR §888.3030 - Single/multiple component bone fixation appliances and accessories. |
| Predicate Devices: | Synthes Medium External Fixation System |
| Device Description: | Synthes Medium External Fixation System - MR Safe is a system of components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamps (four / six position) - MR Safe, the Medium Combination Clamp - MR Safe, the 8.0 mm/11.0 mm Combination Clamp - MR Safe and the Medium Open Adjustable Clamp - MR Safe. Also included in this MR Safe system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the Combination and Multi-Pin Clamps, respectively. These clamp accessories allow dynamization during bone healing and double stacking of the frame. The system accepts Synthes 8.0 mm carbon fiber rods (in lengths from 100 - 500 mm) and Schanz screws (in diameters of 4.0 - 5.0 mm). |

All frame elements are made from non-magnetic materials and are intended for use in the MR environment.

| Intended Use: | Intended for use in the construction of an external fixator frame for the treatment of pediatric and adult fractures. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material: | Stainless steel, titanium alloy and cobalt alloy |
| Substantial Equivalence: | Documentation is provided in this premarket notification that demonstrates that Synthes Medium External Fixation System -- MR Safe is substantially equivalent to other legally marketed devices. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2004

Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K040258

Trade/Device Name: Synthes (USA) Medium External Fixation System - 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: February 3, 2004 Received: February 4, 2004

Dear Ms. Silvestri:

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 - Ms. Angela J. Silvestri

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/dsma/dsmamain.html

Sincerely yours.

b. Mark M. Wilkerson

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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## 2.0 Indications for Use Statement

Page _________________________________________________________________________________________________________________________________________________________________________ of

510(k) Number (if known):

040258

of pediatric and adult fractures.

Device Name:

Synthes (USA) Medium External Fixation System - MR Safe

Indications:

The Synthes (USA) Medium External Fixation System is intended for use in the construction of an external fixator frame for the treatment

Mark N Milliman
Division Sign Off

Division of and Neurologic

040258 510(k) Number_________________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the-Counter Use

(Per 21 CFR 801.109)

CONFIDENTIAL 000004