WASTON Metallic Intramedullary Nail System

K151062 · Changzhou Waston Medical Appliance Co., Ltd. · HSB · Dec 17, 2015 · Orthopedic

Device Facts

• Record ID: K151062
• Device Name: WASTON Metallic Intramedullary Nail System
• Applicant: Changzhou Waston Medical Appliance Co., Ltd.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 17, 2015
• 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

WASTON Metallic Intramedullary Nail System is a temporary orthopedic fixation device for tibial shaft fractures. System components include intramedullary nail, locking screws, and end caps. Used in clinical settings by orthopedic surgeons to stabilize fractures; nail is inserted into the medullary canal of the tibia and secured with locking screws through proximal and distal holes. Provides mechanical stabilization to facilitate bone healing. Benefits include fracture fixation and support for delayed union or pseudarthrosis.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Ti-6Al-4V ELI alloy (ASTM F136). Components: Intramedullary nail, locking screws, end caps. Mechanical testing: Static/dynamic bending and static torsion per ASTM F1264; screw driving torque and pull-out per ASTM F543. Sterilization: Moist heat (autoclave) per ISO 17665-1 to SAL 10^-6. Connectivity: None (mechanical device).

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

• Metallic Intramedullary Nail System (K132078)

Submission Summary (Full Text)

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December 17, 2015

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

Changzhou Waston Medical Appliance Company, Limited % Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K151062

Trade/Device Name: WASTON Metallic Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 30, 2015 Received: November 3, 2015

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARIMENI OE HEALIH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K151062

Device Name

WASTON Metallic Intramedullary Nail System

Indications for Use (Describe) · Simple, compound first- and second-degree tibial shaft fractures · Pseudarthrosis and delayed union

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995

### *DO NOT SEND YOUR COMPEETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

K151062 The assigned 510(k) Number:

- 1. Date of Preparation: 01/13/2015
- 2. Sponsor Identification

CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD. 9 Xihu Road, Wujin Hi-tech Industry Zone, Changzhou, Jiangsu, 213168, China

Establishment Registration Number: Not yet registered

Contact Person: Mr. Jack Lu Position: International Department Director Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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Ref.:M0232014

#### 4. Identification of Proposed Device

Trade Name: WASTON Metallic Intramedullary Nail System Common Name: Intramedullary nail

### Regulatory Information

Classification Name: rod, fixation, intramedullary and accessories; 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

### Device Description

The WASTON Metallic Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments.

The intramedullary nail is available in a variety of lengths 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.

All implants of Metallic Intramedullary Nail System are manufactured from Ti-6Al-4V alloy that meets the requirements of ASTM F-136.

The proposed devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

- ર . Identification of Predicate Device
510(k) Number: K132078 Product Name: Metallic Intramedullary Nail System

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- 6. Non-Clinical Test Conclusion
Non clinical 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 2012): Standard specification and test methods for A intramedullary fixation devices.
- ASTM F543-13: Standard specification and test method for metallic medical bone screws. >
- ASTM F136-13: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI A (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56401).
- > ASTM F138-13, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
- > ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

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Ref.:M0232014

#### Substantially Equivalent (SE) Comparison 8.

| Item | Proposed Device(s) | Predicate Device<br>K132078 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product Code | HSB | Same |
| Regulation Number | 21 CFR 888.3020 | Same |
| Intended Use | Simple, compound first- and second-degree tibial shaft fractures<br>Pseudarthrosis and delayed union | Same |
| Configuration | Nail, Screw and End Cap | Same |
| Sterile | The devices are supplied non-sterile, it should be sterilized prior to use by professional and the sterilization should achieve SAL 1×10-6 | Same |
| Single Use | Yes | Same |
| Material | Titanium Alloy (TI -6A1-4 V ELI) | Same |
| Physical<br>Specification | Nail Proximal/Distal diameter: φ10/φ8 mm, φ10/φ9 mm, φ10/φ10 mm;<br>Length: 240~340 mm | Same |
| | Screw Diameter: φ6mm<br>Length: 20~95 mm | Similar |
| | | |
| Mechanical<br>Specification | Nail Static bending, Dynamic bending and Static Torsional performance were tested per ASTM F1264 | Same |
| | Screw Dynamic bending performance was tested per ASTM F1264;<br>Driving torque and pull-out performance were tested per ASTM F543 | Same |
| | | |

Table 1 Comparison of Technology Characteristics

#### Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.