SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820

K984364 · Syntec Scientific Corp. · KTT · Mar 2, 1999 · Orthopedic

Device Facts

• Record ID: K984364
• Device Name: SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820
• Applicant: Syntec Scientific Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Mar 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Small Orthopedic Fixation System is provided non-sterile. The implants by the External Fixation Instrument may be used for highly comminuted closed fracture of hand, wrist, foot and tarsus ; for severe open fractures; for complex soft-tissue damages; or for dislocated joint fractures.

Device Story

Small Orthopedic Fixation System consists of surgical instruments and implants (Schanz Screws and Kirschner Wires). Used by surgeons in clinical settings for orthopedic stabilization. Implants are manually inserted into bone to provide external fixation for fractures and joint dislocations. System provides mechanical stabilization of bone segments to facilitate healing. No electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technological similarities to the predicate device.

Technological Characteristics

Constructed from stainless steel. System comprises manual instruments, Schanz Screws (1.6-3.0 mm diameter, 150-200 mm length), and Kirschner Wires with threaded tips (3.0/4.0 mm diameter, 80 mm length). Mechanical fixation device; non-sterile; no software or electronic components.

Indications for Use

Indicated for patients with highly comminuted closed fractures of the hand, wrist, foot, and tarsus; severe open fractures; complex soft-tissue damages; or dislocated joint 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

• Electro-Biology -- EBI Small External Fixator (S/E/F/)

Submission Summary (Full Text)

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3/2/99

## 510(k) Summary of Safety and effect

- Sponsor: Syntec-Taichung Medical Instruments Co., Ltd. A 2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. 509 Phone / FAX: [phone] Contact Person: Ted Y. Shi
- A Proprietary Name : Syntec-Taichung Non-sterile Small Orthopedic Fixation System
- A Common Name : Small External Fixation System
- > Classification Status : Class II, CFR 888.3030
- A Device Product Code : 87 KTT
- > Material: This device is manufactured from commercially stainless steel.
- > Indication for Use :

The Small Orthopedic Fixation System is provided non-sterile. The implants by the External Fixation Instrument may be used for highly comminuted closed fracture of hand, wrist, foot and tarsus ; for severe open fractures; for complex soft-tissue damages; or for dislocated joint fractures.

## A Description of the Device :

The Small Orthopedic Fixation System makes up of instrument and implants. The instrument is utilized with the implants. The implants are divided two kinds of styles: Schanz Screw, and Kirschner Wire. The dimension of the Schanz Screw ranges in thread diameter from 1.6 to 3.0 mm, thread length 15 mm, and total length 150, 200 mm; The dimension of Kirschner Wire with Threaded Tip ranges in thread diameter from 3.0/4.0 mm, total length from 80 mm.

## A Basis of Substantial Equivalence :

A comparison of the non-sterile Small Orthopedic Fixation System described in this submission and Flectro-Biology -- EBI Small External Fixator (S/E/F/) has been commercial device that they are very similar or identical in terms of design, sizes, material and appliance. Based on this information, Syntec-Taichung (Taiwan) believes

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that the non-sterile Small Orthopedic Fixation System is substantially equivalent to Electro-Biology -- EBI Small External Fixator (S/E/F/).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 1999

Mr. Ted Y. Shi President Syntec-Taichung Medical Instruments Company Limited 2, Kung San Road, Chuan Shing Industrial Zone Shen Kang, Chang Hua, Taiwan 509

Re : K984364 Syntec-Taichung (Taiwan) Non-sterile Small Orthopedic Fixation System Requlatory Class: II Product Code: KTT December 2, 1998 Dated: Received: December 7, 1998

Dear Mr. Shi:

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 The general controls provisions of the Act 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 Requlations, 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 (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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.

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Page 2 - Mr. Ted Y. Shi

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.

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell Rogers

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

Enclosure

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Page _ of ____________________________________________________________________________________________________________________________________________________________________

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__ Syntec-Taichung Non-sterile Small Orthopedic Fixation System

Indications for use:

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The Small Orthopedic Fixation System is provided non-sterile. The implants by the External Fixation Instrument may be used for highly comminuted closed fracture of hand, wrist, foot and tarsus ; for severe open fractures; for complex soft-tissue damages; or for dislocated joint fractures.

## (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)

(Optional Format 1-2-96)

Nuan Luyano for CMU

(Division Sign-Off)
Division of General Restoreepy Devices
510(k) Number. 11.5 K984364