INTRAMEDULLARY NAIL SYSTEM

K121312 · Weigao Orthopaedic Device Co., Ltd. · HSB · Oct 24, 2012 · Orthopedic

Device Facts

• Record ID: K121312
• Device Name: INTRAMEDULLARY NAIL SYSTEM
• Applicant: Weigao Orthopaedic Device Co., Ltd.
• Product Code: HSB · Orthopedic
• Decision Date: Oct 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Simple, compound first- and second-degree tibial shaft fractures Pseudarthrosis and delayed union

Device Story

Intramedullary Nail System is a temporary fixation device for tibial fracture stabilization. System components include intramedullary nail, locking screws, and end cap. Nail is inserted into the tibia to provide structural support; locking screws are passed through proximal and distal holes to prevent rotation and axial compression; end cap is screwed into the nail end to allow intraoperative length adjustment and prevent tissue ingrowth. Used by orthopedic surgeons in clinical/surgical settings. Device provides mechanical stabilization to facilitate bone healing and patient recovery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Constructed from Ti-6Al-4V alloy (ASTM F-136). Mechanical fixation via intramedullary nail, locking screws, and end cap. Tested per ASTM F1264-03 (static/dynamic bending, torsion) and ASTM F543-07 (pull-out strength).

Indications for Use

Indicated for patients with simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis, and delayed union.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Orthofix Titanium Nailing System (K053261)

Submission Summary (Full Text)

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Exhibit #1 510(k) Summary

# Exhibit #1 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K121312

- Date of Submission: OCT 16, 2012 1.
- 2. Sponsor

Weigao Orthopaedic Device Co., Ltd No. 26 Xiangjiang Road, Tourist Resorts, Weihai Shandong, 264203, China Establishment Registration Number: 3006639944 Contact Person: Han Wang Position: Quality & Technique Manager Tel: [phone] Fax: [phone] Email: [e-mail]

3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]

- 4. Proposed Device Identification
Proposed Device Name: Intramedullary Nail System Classification: II Product Code: HSB Regulation Number: 21 CFR 888.3020 Review Panel: Orthopedic Intended Use Statement:

- · Simple, compound first- and second-degree tibial shaft fractures
- · Pseudarthrosis and delayed union

EI-I

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#### Additional Information II for K121312

Exhibit #1 510(k) Summary

Project #:M0012012

- న. Predicate Device Identification
510(k) Number: K053261 Product Name: Orthofix Titanium Nailing System Submitter: R. Sheridan Consulting. LLC

#### 6. Device Description

The Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. It consists of Intramedullary nail, Locking screw and End cap.

The Intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. The Locking screw passes through the holes at the proximal distal sections of intramedullary nail for preventing rotation and axial compression. The End cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads.

All implants of Intramedullary Nail System are manufactured from Ti-6AI-4V alloy that meets the requirements of ASTM F-136. The materials are wildly used in the industry with well known biocompatibility. No new materials are used in the development of this implant.

- 7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM F1264-03 (Reapproved 2007), Standard Specification and Test Methods for Intramedullary Fixation Devices, including the following items:

- Static bending test .
- Static torsion test
- . Dynamic bending test

ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws- pullout strength, including the following item:

- . Pull out test
- 8. Substantially Equivalent Conclusion

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Additional Information II for K121312

Exhibit #1 510(k) Summary Project #:M0012012

The proposed device, Intramedullary Nail System, is determined to be Substantially Equivalent (SE) to the predicate device, K053261 Orthofix Titanium Nailing System, in respect of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Weigao Orthopaedic Device Company, Limited % Mid-Link Consulting Company, Limited Ms. Diana Hong General Manager PO Box 237-023 Shanghai, China 200237

Re: K121312

Trade/Device Name: Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 16, 2012 Received: October 22, 2012

OCT
24
2012

Dear Ms. Hong:

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. 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 801); medical device reporting (reporting of medical

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### Page 2 - Ms. Diana Hong

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/Aefault.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section II Indications for Use

510(k) Number: K1213/2
Device Name: Intramedullary Nail System

Indications for Use:

- · Simple, compound first- and second-degree tibial shaft fractures
· Pseudarthrosis and delayed union

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

## OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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K121312

510(k) Number