SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM

K011034 · Synthes (Usa) · KTT · Jun 27, 2001 · Orthopedic

Device Facts

• Record ID: K011034
• Device Name: SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Jun 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Synthes Medium External Fixation System is intended for the construction of an external fixator frame for the treatment of pediatric and adult fractures.

Device Story

System of components forming external fixator frame for pediatric and adult fracture treatment. Components include Medium Multi-Pin Clamps, Medium Combination Clamps, Medium Dynamization Clips, and Medium Rod Attachments. Used with 8.0 mm carbon fiber rods (100-500 mm length) and 4.0, 4.5, and 5.0 mm diameter Schanz screws. Clamps secure pins to rods to stabilize fractures. Dynamization clips and rod attachments allow for bone healing dynamization and frame double-stacking. Operated by surgeons in clinical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Stainless steel, titanium alloy, and carbon fiber reinforced epoxy (CFRE). System consists of clamps, rods, and accessories for external fixation. Mechanical assembly; no software or energy source.

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

• Howmedica Hoffmann® II External Fixation System
• Synthes Dynamization Clip

Submission Summary (Full Text)

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K011034

# JUN 2 7 2001

#### 3.0 510(k) Summary

Sponsor:

Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone]

Contact: Bonnie Smith

Synthes Medium External Fixation System Device Name:

Classification: The classification of the Synthes Medium External Fixation System is Class II, as per Title 21 of the Code of Federal Regulations, Sections 888.3030: "Single/multiple component bone fixation appliances and accessories" and 888.3040: "Smooth or threaded metallic bone fixation fastener". The instruments used with this system are considered Class I Exempt, as per 21 CFR 888.4540: "Orthopedic manual surgical instruments".

Predicate Device: The predicate device for the Synthes Medium External Fixation System is the Howmedica Hoffmann® II External Fixation System. Synthes Medium Dynamization Clip, a component accessory to the system, is similar to the currently marketed Synthes Dynamization Clip.

Synthes Medium External Fixation System is a system of Device Description: components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamp and the Medium Combination Clamp. Also included in the system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the clamps that allow dynamization during bone healing and double stacking of the frame, respectively. The system is used with Synthes 8.0 mm carbon fiber rods ranging in lengths from 100 - 500 mm. System pin clamps accept Schanz screws in diameters of 4.0, 4.5 and 5.0 mm.

The Synthes (USA) Medium External Fixation System is intended for Intended Use: use in the construction of an external fixator frame for the treatment of pediatric and adult fractures.

- Materials: Clamps -Stainless steel and titanium alloy Dynamization Clip -- Stainless steel Rod Attachment - Stainless steel and titanium alloy Rods - Carbon fiber reinforced epoxy (CFRE)
Premarket Notification 510(k): Synthes (USA) Medium External Fixation System CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

JUN 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K011034

Trade Name: Synthes (USA) Medium External Fixation System Regulation Number: 888.3030 Regulatory Class: Class II Product Code: KTT Dated: April 4 , 2001 Received: April 5, 2001

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Bonnie J. Smith

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mhichalairn fr

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

Enclosures

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### 2.0 Indications for Use Statement

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510(k) Number (if known):

K011034

Device Name:

Synthes (USA) Medium External Fixation System

INDICATIONS:

Synthes Medium External Fixation System is intended for the construction of an external fixator frame for the treatment of pediatric and adult fractures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109) OR

510(k) Numb

Over-the-Counter Use _

BMitchell/RAduu
(Division Sign-Off)

Division of General, Restorative Premarket Notification 510(k): Synthes (USA) Medium External Fixation System and Neurological Devices CONFIDENTIAL

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