Sonoma Fifth Metatarsal Repair System

K161371 · Sonoma Orthopedic Products, Inc. · HSB · Feb 24, 2017 · Orthopedic

Device Facts

• Record ID: K161371
• Device Name: Sonoma Fifth Metatarsal Repair System
• Applicant: Sonoma Orthopedic Products, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Feb 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures of the fifth metatarsal, including Jones, avulsion and shaft fractures.

Device Story

The Sonoma Fifth Metatarsal Repair System is an intramedullary fixation device for fifth metatarsal fractures. It consists of a nail, end caps, and surgical instruments. Unlike traditional rods, it features the ActivLoc fixation gripper system at the distal end, which provides distal fixation without requiring screws, threads, or K-wires. The device is used by orthopedic surgeons in a clinical or surgical setting to stabilize fractures. The surgeon inserts the nail into the intramedullary canal; the gripper system is deployed to secure the distal end, and the compressive end cap is applied to provide stability. This system aims to facilitate bone healing by maintaining fracture alignment and stability, potentially reducing the need for additional hardware like distal locking screws.

Clinical Evidence

Bench testing only. Engineering analysis and mechanical testing in a clinically relevant fracture model demonstrated equivalence to the predicate in cyclic and static fatigue. Additional testing confirmed adequate fixation during insertion and over time. The device meets pyrogen limit specifications.

Technological Characteristics

Intramedullary fixation rod system. Materials: 316 stainless steel (ASTM F138). Features: ActivLoc distal fixation gripper system (mechanical expansion) and compressive end cap. Dimensions are within the range of the predicate device. Sterilization: Not specified.

Indications for Use

Indicated for fixation of fractures and osteotomies of the fifth metatarsal, including Jones, avulsion, and shaft fractures in patients requiring intramedullary stabilization.

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

• IP-XS Compression Nail (K032548)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble water or fabric.

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

February 24, 2017

Sonoma Orthopedic Products, Inc. % Dawn Norman Executive Vice President MRC-X, LLC 6075 Poplar Avenue Suite 500 Memphis, Tennessee 38119

Re: K161371

Trade/Device Name: Sonoma Fifth Metatarsal Repair System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 26, 2017 Received: January 27, 2017

Dear Ms. Norman:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (21 CFR 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,

# Vincent J. Devlin -S

for

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

Enclosure

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## Indications for Use

510(k) Number (if known) K161371

### Device Name

Sonoma Fifth Metatarsal Repair System

Indications for Use (Describe)

The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures of the fifth metatarsal, including Jones, avulsion and shaft fractures.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## K161371

## 510(k) Summary

Sonoma Fifth Metatarsal Repair System February 24, 2017

| Company: | Sonoma Orthopedics Products, Inc.<br>1388 Busch Parkway<br>Buffalo Grove, IL 60089<br>Phone: [phone]<br>Fax: [phone] | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Establishment Registration: | 3007038372 | |
| Primary Contact: | Dawn Norman, MS<br>Exec. Vice President<br>MRC-X, LLC<br>6075 Poplar Avenue, Suite 500<br>Memphis, TN, 38119, USA<br>Phone: [phone]<br>Fax: [phone] | |
| Company/Secondary Contact: | Kyle Lappin<br>Sonoma Orthopedics Products, Inc.<br>1388 Busch Parkway<br>Buffalo Grove, IL 60089<br>Phone: [phone]<br>Fax: [phone] | |
| Trade Name: | Sonoma Fifth Metatarsal Repair System | |
| Common Name: | Rod, Fixation, Intramedullary and Accessories | |
| Classification: | Class II | |
| Classification Name: | Intramedullary fixation rod | |

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| Panel: | 87 - Orthopedic |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | HSB |
| Predicate Device: | K032548 IP-XS Compression Nail |
| Device Description: | The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures and osteotomies of the fifth metatarsal, including Jones, avulsion, and shaft fractures. The Fifth Metatarsal Repair System includes the Sonoma Fifth Metatarsal Nail, End Caps and related instruments. Sonoma's Fifth Metatarsal Nail differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the distal end of the rod to supplement distal fixation without the use of screws, threads or K-wires. The implants are composed of 316 stainless steel per ASTM F138. |
| Indications for Use: | The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures and osteotomies of the fifth metatarsal, including Jones, avulsion and shaft fractures. |
| Substantial Equivalence: | The intended use of the subject device is substantially equivalent to the predicate device. The indications for use for the subject |

- device are limited to the fifth metatarsal as opposed to additional anatomic locations indicated for the predicate device. The material of the subject device is the same as the IP-XS Nails (K032548). The dimensions of the subject device are within the range of the predicate device. The subject device utilizes a compressive end cap similar to the predicate IP-XS nail. Thus, the subject device is substantially equivalent to the predicate device.
- Performance Testing: Engineering analysis and mechanical testing in a clinically relevant fracture model confirmed that the subject rods are equivalent to the predicate device in cyclic and static fatigue testing. Additional testing was performed demonstrating adequate fixation both during insertion and over time. The Sonoma Fifth Metatarsal Repair System meets the pyrogen limit specifications.