Sonoma Fibula Repair System

K142945 · Sonoma Orthopedic Products, Inc. · HSB · Jan 22, 2015 · Orthopedic

Device Facts

• Record ID: K142945
• Device Name: Sonoma Fibula Repair System
• Applicant: Sonoma Orthopedic Products, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Jan 22, 2015
• 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.

Device Story

The Sonoma Fibula Repair System is an orthopedic implant set for fibula fracture fixation. It consists of a fibula rod, bone screws, and an end cap. Unlike traditional intramedullary nails, the rod features an ActivLoc fixation gripper system at the proximal end, enabling proximal fixation without screws. The device is used by orthopedic surgeons in a clinical or surgical setting to stabilize fractures. The surgeon inserts the rod into the intramedullary canal; the gripper system secures the proximal end, while distal screws provide additional stability. This system aims to provide secure fracture fixation, potentially reducing the need for proximal screw placement and facilitating bone healing.

Clinical Evidence

Bench testing only. Engineering analysis and mechanical testing were performed in accordance with ASTM F1264-03(07). Results confirmed equivalence to predicate Acumed rods in cyclic bending fatigue, static bending, and static torsion.

Technological Characteristics

Implants composed of 316 stainless steel per ASTM F138. Features intramedullary rod with proximal ActivLoc fixation gripper system. Distal fixation via 2.7 mm diameter screws. Mechanical performance validated per ASTM F1264-03(07).

Indications for Use

Indicated for the fixation of fibula 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

• Acumed Small Bone Locking Rod System II (K071994)
• 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

January 22, 2015

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

Re: K142945

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: October 25, 2014 Received: October 28, 2014

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

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Page 2 - Ms. Dawn Norman

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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 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/Resourcesfor You/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.

# Lori A. Wiggins -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K142945

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.

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 October 9, 2014

| Company: | Sonoma Orthopedics Products, Inc<br>1388 Busch Parkway<br>Buffalo Grove, IL 60089 |
|----------|-----------------------------------------------------------------------------------|
| Phone: | 707-526-1335 |
| Fax: | 707-526-2022 |

Establishment 3007038372 Registration:

- Primary Contact: Dawn Norman, MS Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, TN 38133, USA Phone: [phone] Fax: [phone]
## Company/Secondary Contact:

Kyle Lappin

Sonoma Orthopedics Products, Inc 1388 Busch Parkway Buffalo Grove, IL 60089 Phone: [phone] 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 | |
| Predicate Devices: | K071994 Acumed Small Bone Locking Rod System II<br>K031438 Acumed Small Bone Locking Rod System II | |
| Device Description: | The Sonoma Fibula Repair System includes all implants and<br>instruments required for the fixation of fibula fractures. The Fibula<br>Repair System includes the Sonoma Fibula Rod, Sonoma Bone<br>Screws, End Cap and related instruments. Sonoma's Fibula Rod<br>differs from traditional nails or rods as it utilizes Sonoma's<br>ActivLoc® fixation gripper system at the proximal end of the rod<br>to allow for proximal fixation without the use of screws. The<br>implants are composed of 316 stainless steel per ASTM F138. | |
| Indications for Use: | The Sonoma Fibula Repair System is intended for use in the<br>fixation of fibula fractures. | |
| Substantial Equivalence: | The intended use of the subject device is the same as the predicate<br>devices. The indications for use for the subject device is limited to<br>the fibula as opposed to additional anatomical locations for the<br>predicate devices. The material of the subject device is the same<br>as the Acumed Small Bone Locking Rod System (K071994). The<br>dimensions of the subject device are within the range of the<br>predicate devices for proximal and distal diameter, lateral bend,<br>length, screw orientation, and placement of screws from the end of<br>the rod. The subject device utilizes 2.7 mm diameter distal screws<br>as opposed to 3.5 mm diameter distal screws. The subject devices<br>use three (3) distal screws as opposed to two (2) distal screws.<br>Thus, the subject device is substantially equivalent to the predicate<br>devices. | |
| Performance Testing: | Engineering analysis and mechanical testing according to ASTM<br>F1264-03(07) confirmed that the subject rods are equivalent to<br>predicate Acumed rods in cyclic bending fatigue, static bending<br>and static torsion. | |

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