K Number

Device Name

SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420

Manufacturer

SYNTEC SCIENTIFIC CORP.

Date Cleared

1998-12-16

(72 days)

Product Code

HWC

Regulation Number

888.3040

Intended Use

The bone plates and screws are provided non-sterile. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

Device Description

This system makes up of non-sterile bone plate and screw implants. The plates are devices, which are fastened to bone for purpose of providing fixation. They are principally differentiated by their function. Thus there are four kind of styles: Dynamic Compression Plate (DCP), tubular, special, and mini. The shape of the plate is an adaptation of the plate to the local anatomy and doesn't denote any function. Thus the name depends on the biomechanical function the plate is performing. Every plate is divided various types as following: DCP (narrow, narrow lengthening, broad, and broad lengthening straight), Tubular (semi-tubular, one-third, and quarter), Special (L-shaped, T-shaped, spoon, cobra, lateral tibial head, condylar buttress, head, and hook), and Mini (T-shaped, Straight, L-shaped, condylar, special, and reconstruction). The plates are manufactured from commercially 316 LS stainless steel; however, all of titanium plates except mini are included above-style. They range in thickness from 1.0 to 5.0 mm, width from 3.8 to 17 mm, length from 17 to 262 mm, and hole number from 2 to 20 holes. On the other hand, the screws used either to fasten plates or similar devices onto bone, or. as lag screws, to hold together fragments of bone. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Thus there are four kind of style: cortex, cancellous, malleolar, and cannulated. All screws have a hexagonal recess; this feature has proven itself to be of great advantage at the time of the screw removal and insertion. The screws are manufactured from commercially 316 LS stainless steel. However, all of titanium screws except malleolar were included above-style. They range in thread diameter from 1.5 to 7.3 mm, total length from 6 to 150 mm, and hexagonal socket width from 1.5, 2.5,or 3.5 mm.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Synthes bone plate/screw

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses solely on the physical characteristics and materials of bone plates and screws, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
The device is intended to treat fractures of bones, which is a therapeutic purpose aimed at restoring bone integrity and function.

Diagnostic

The device is described as bone plates and screws intended to treat fractures by providing fixation, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly outlines physical bone plates and screws, which are hardware components, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Description: The provided description clearly states that the device consists of "non-sterile bone plate and screw implants." These are physical implants designed to be surgically placed inside the body to fix fractures.
Intended Use: The intended use is to "treat fractures of various bones." This is a therapeutic intervention performed in vivo (inside the body).

The device described is a surgical implant used for orthopedic fixation, not a diagnostic tool that analyzes biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

87 HRS, 87 HWC

Device Description

The plates are manyfactured from commercially 316 LS stainless steel; however, all of titanium plates except mini are included above-style. They range in thickness from 1.0 to 5.0 mm, width from 3.8 to 17 mm, length from 17 to 262 mm, and hole number from 2 to 20 holes.

On the other hand, the screws used either to fasten plates or similar devices onto bone, or. as lag screws, to hold together fragments of bone. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Thus there are four kind of style: cortex, cancellous, malleolar, and cannulated. All screws have a hexagonal recess; this feature has proven itself to be of great advantage at the time of the screw removal and insertion.

The screws are manufactured from commercially 316 LS stainless steel. However, all of titanium screws except malleolar were included above-style. They range in thread diameter from 1.5 to 7.3 mm, total length from 6 to 150 mm, and hexagonal socket width from 1.5, 2.5,or 3.5 mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Synthes bone plate/screw

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

Summary

1983495

510(k) Summary of Safety and effectiveness

Sponsor : Syntec-Taichung Medical Instruments Co., Ltd. A 2. Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. 509 Phone / FAX: 886-4-7987099 / 886-4-7987077 Contact Person: Ted Y. Shi
Proprietary Name : Syntec-Taichung Non-sterile Bone Plate and Screw Implants >
Common Name : Bone fixation plate and screw
Classification Name : Class II, CFR 888.3030 and 888.3040 >
Device Product Code : 87 HRS and 87 HWC
A Material :

The non-sterile bone plates and screws are manufactured from commercially 316 LS stainless steel and titanium alloy (Ti-6Al-4V).

A Indication for Use :

A Description of the Device :

Plate Name	Geometry Shape
DCP	narrow, narrow lengthening, broad, and broad lengthening
straight
Tubular	semi-tubular, one-third, and quarter
Special	L-shaped, T-shaped, spoon, cobra, lateral tibial head, condylar

buttress, head, and hook

Mini

T-shaped, Straight, L-shaped, condylar, special, and reconstruction

A Basis of Substantial Equivalence :

A comparison of the non-sterile bone plate and screw implants described in this submission and Synthes bone plate/screw shows that they are very similar or identical in terms of design, sizes, material and appliance. Based on this information, Syntec-Taichung believes that the non-sterile bone plate and screw implants are substantially equivalent to Synthes bone plate and bone screw.

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 1998

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

Re: K983495

Syntec-Taichung Non-sterile Bone Plate and Screw Implants Regulatory Class: II Product Codes: HWC and HRS Dated: November 25, 1998 Received: December 1, 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 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(t)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

1. The package insert must prominently state that the device is intended for the specific use(s) described in the enclosure only: and

Page 2 - Mr. Ted Y. Shi

1. You may not label or in any way promote this device for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, "WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
  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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the

Page 3 - Mr. Ted Y. Shi

Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ___ Syntec-Taichung Non-sterile Bone Plate and Screw Implants____________________________________________________________________________________________________

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter-Use_
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(Per 21 CFR 801.109) that the model is trained on.

(Division Sign-Off)
Division of General Restorative Devices

(Optional Format 1-2-96)
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510(k) Number	K983495
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