Sonoma Fibula Repair System

K160069 · Sonoma Orthopedics Products, Inc. · HSB · Mar 10, 2016 · Orthopedic

Device Facts

• Record ID: K160069
• Device Name: Sonoma Fibula Repair System
• Applicant: Sonoma Orthopedics Products, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Mar 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.

Device Story

The Sonoma Fibula Repair System is an orthopedic implant set for fibula fracture and osteotomy fixation. It consists of a fibula rod, bone screws, and an end cap. The rod features an ActivLoc fixation gripper system at the proximal end, enabling proximal fixation without requiring screws. The system is used by orthopedic surgeons in a clinical or surgical setting to stabilize bone segments. The device provides mechanical support to facilitate bone healing. Implants are manufactured from 316 stainless steel.

Clinical Evidence

No clinical data provided. No performance testing was performed for the additional indication of osteotomies.

Technological Characteristics

Implants are composed of 316 stainless steel per ASTM F138. The system utilizes an intramedullary rod with an ActivLoc fixation gripper system for proximal fixation. The device is a mechanical orthopedic fixation system.

Indications for Use

Indicated for the fixation of fibula fractures and osteotomies in patients requiring orthopedic 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

• Sonoma Fibula Repair System (K142945)
• Acumed Small Bone Locking Rod System II (K071944)
• Acumed Small Bone Locking Rod System II (K031438)

Submission Summary (Full Text)

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

Sonoma Orthopedics Products, Incorporated % Ms. Dawn Norman Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133

March 10, 2016

Re: K160069

Trade/Device Name: Sonoma Fibula Repair System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 12, 2016 Received: January 13, 2016

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 Parts 801); medical device reporting (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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K160069

Device Name

Sonoma Fibula Repair System

#### Indications for Use (Describe)

The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.

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)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) Summary

Sonoma Fibula Repair System January 12, 2016

| Company: | Sonoma Orthopedics Products, Inc<br>1388 Busch Parkway<br>Buffalo Grove, IL 60089<br>Phone: [phone]<br>Fax: [phone] | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Establishment<br>Registration: | 3007038372 | | |
| Primary Contact: | Dawn Norman, MS<br>Managing Partner<br>Memphis Regulatory Consulting, LLC<br>3416 Roxee Run Cove<br>Bartlett, TN 38133, 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 Fibula Repair System | | |
| Common Name: | Rod, Fixation, Intramedullary and Accessories | | |
| Classification: | Class II | | |
| Regulation Number: | 888.3020 | | |
| Panel: | 87- Orthopedic | | |
| Product Code: | HSB | | |

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| Predicate Devices: | K142945 | Sonoma Fibula Repair System |
|--------------------|---------|-----------------------------------------|
| | K071944 | Acumed Small Bone Locking Rod System II |
| | K031438 | Acumed Small Bone Locking Rod System II |

- Device Description: The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures and osteotomies. The Sonoma Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.
#### Indications for Use: The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.

- Substantial Equivalence: The intended use of the subject device is the same as the Acumed predicate devices. The indications for use for the subject device is limited to the fibula as opposed to additional anatomical locations for the Acumed predicate devices. There are no changes to the subject components or accessories compared to the predicate Sonoma Fibula Repair System (K142945). Thus, the subject device is substantially equivalent to the predicate devices.
- Performance Testing: No performance testing was performed associated with the additional indication of osteotomies for the Sonoma Fibular Rod System.