Syntec Non-Sterile Steinmann Pins System

K200933 · Syntec Scientific Corporation · JDW · May 5, 2020 · Orthopedic

Device Facts

• Record ID: K200933
• Device Name: Syntec Non-Sterile Steinmann Pins System
• Applicant: Syntec Scientific Corporation
• Product Code: JDW · Orthopedic
• Decision Date: May 5, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Steinmann pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

Device Story

Syntec Non-Sterile Steinmann Pins System consists of metallic pins used for bone fixation, osteotomies, and as guide pins for other implants. Provided non-sterile, these pins are intended for use by surgeons in clinical settings. The device functions as a mechanical fastener to stabilize bone fragments during healing. The system is a modification of the manufacturer's previously cleared device (K983121). The pins are inserted into bone to provide immobilization. The device does not include software or electronic components. It has not been evaluated for MR safety; scanning patients with this device may cause injury.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing confirming conformance to ASTM F138-13, ASTM F366-10, and ISO 5838-1 standards.

Technological Characteristics

Fabricated from stainless steel (SUS316L) per ASTM F138-13. Conforms to ASTM F366-10 and ISO 5838-1. Mechanical fixation device; no energy source, software, or electronic components.

Indications for Use

Indicated for fracture fixation, healing of bone fragments, osteotomies requiring immobilization, and as guide pins for other implants in patients requiring orthopedic bone fixation.

Regulatory Classification

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.

Predicate Devices

• Non-Sterile Kirschner Wires and Steinmann Pins (K983121)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

Syntec Scientific Corporation % Nicole Tseng Senior Regulatory Affairs Specialist Syntec Scientific Corporation - Taipei Office 3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist., Taipei, Taiwan 10652 R.O.C.

#### Re: K200933

Trade/Device Name: Syntec Non-Sterile Steinmann Pins System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDW, HTY Dated: April 7, 2020 Received: April 7, 2020

#### Dear Nicole Tseng:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

May 5, 2020

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Brent L. Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K200933

Device Name

Syntec Non-Sterile Steinmann Pins System

Indications for Use (Describe)

The Steinmann pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/1 description: The image shows the logo for Syntec Scientific. The logo consists of a red circle with a blue "S" inside of it. The text "SYNTEC SCIENTIFIC" is written below the logo. The image also contains the text "No.2, Cha".

SYNTEC SCIENTIFIC CORPORATION

No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kanq, Chang Hua Hsien, Taiwan R.O.C. TEL: [phone] E-mail: [e-mail] Regulatory Affairs Specialist

# This summary of 510(k) information is being submitted in accordance with the requirement of SMDA 1990 and 21CFR 807.92.

# Special 510(k) Summary

| Submitted By: | Syntec Scientific Corporation |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Syntec Scientific Corporation - Taipei Office<br>3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist.,<br>Taipei, Taiwan 10652 R.O.C. |
| | TEL: [phone]<br>FAX: [phone] |
| Date of Summary Prepared: | 2020-03-31 |
| Contact person: | Nicole Tseng |
| Name of the device: | Senior Regulatory Affairs Specialist |
| Trade or proprietary name: | Syntec Non-Sterile Steinmann Pins System |
| Common or usual name: | Smooth Or Threaded Metallic Bone Fixation Fastener |
| Product code: | JDW, HTY |
| Regulation number: | 21CFR888.3040 |
| Class: | Class II |
| Modified devices: | Non-Sterile Kirschner Wires and Steinmann Pins<br>(K983121) |
| Prior Submission: | None |

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Image /page/4/Picture/1 description: The image shows the logo for Syntec Scientific. The logo consists of a large orange circle overlapping a blue letter 'S'. Below the symbol, the words 'SYNTEC SCIENTIFIC' are written in a serif font, with 'SYNTEC' on the top line and 'SCIENTIFIC' on the bottom line.

YNTEC SCIENTIFIC CORPORATION

No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kanq Chang Hua Hsien, Taiwan R.O.C. TEL: [phone] E-mail: [e-mail] Regulatory Affairs Specialist

### 1. Description of the Device

The Syntec Non-Sterile Steinmann Pins System is modify from our own device from K983121-Non-Sterile Kirschner Wires and Steinmann Pins product systm.

### 2. Intended Use

The Steinmann pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

## 3. Technological Characteristics Comparison to Previous Device

The Syntec Non-Sterile Steinmann Pins System is identical to our previous cleared for market in 510(k) K983121-Non-Sterile Kirschner Wires and Steinmann Pins product system and essentially Substantially Equivalent (SE) to the predicate. The indications for use for this system are patterned after the predicate devices and supported by an extensive collection of literature references.

## 4. Technological Characteristics:

The modify Pins are fabricated from stainless steel (SUS316L) per ASTM F138-13.The design feature for the Non-Sterile Steinmann Pins System is similar to the predicate devices including dimensions, shape, style and sizes.

## 5. Summary of Performance Data (Nonclinical and/or Clinical)

#### *Clinical Test

Clinical data and conclusions were not needed for these devices.

#### *Non-Clinical Test

Performance test are not required to support substantially equivalent in special 510k. The Syntec Non-Sterile Steinmann Pins System was considered for conformance to dimensional and material mechanical property standards ASTM F138-13, ASTM F366 -10 and ISO 5838-1. All items in the scope were in conformance with those standards and are therefore substantially equivalent to the predicate devices.

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Image /page/5/Picture/1 description: The image shows a logo for Syntec Scientific. The logo features a large red circle with the letters "OS" inside, with the "S" being in dark blue. Below the circle and letters, the words "SYNTEC SCIENTIFIC" are written in a smaller, black font.

YNTEC SCIENTIFIC CORPORATION

No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kanq Chang Hua Hsien, Taiwan R.O.C. TEL: [phone] E-mail: [e-mail] Regulatory Affairs Specialist

In addition, Syntec Non-Sterile Steinmann Pins System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

#### *Conclusions

The analysis information presented in this submission demonstrates that the subject device is substantially equivalent to the predicate devices.

#### 6. Substantial Equivalence

We believe that Syntec Non-Sterile Steinmann Pins System does not add new or increased risks and complications, based on current engineering technology and clinical results published about pins as well as based on what has been previously cleared by FDA.

In conclusion, the Syntec Non-Sterile Steinmann Pins System has the same intended uses and indications, technological characteristics, and principles of operation to the predicate device. Thus, the Syntec Non-Sterile Steinmann Pins System is substantially equivalent in design, configuration, function, and indications for use to the previous own device.