SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)

K100112 · Sonoma Orthopedic Products, Inc. · HSB · Sep 28, 2010 · Orthopedic

Device Facts

• Record ID: K100112
• Device Name: SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
• Applicant: Sonoma Orthopedic Products, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Sep 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sonoma CWG Clavicle fracture repair device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Device Story

The Sonoma CWG Clavicle Fracture Repair Device is a 316L stainless steel intramedullary fixation rod designed for surgical repair of clavicle fractures, mal-unions, or non-unions. The device features internal grippers and a compression screw to stabilize fracture fragments and provide compression. It is implanted by a surgeon in a clinical setting. The device functions by providing mechanical fixation and anatomical alignment of the clavicle, similar to existing intramedullary pins. By securing the fracture site, the device facilitates bone healing and restores structural integrity to the clavicle. It is intended for prescription use only.

Clinical Evidence

No clinical data. Evidence consists of bench testing and cadaveric studies. Bench testing included static bending, torque, and cyclic bending fatigue per ASTM F1264-03. Cadaveric testing compared the subject device to the predicate Sonoma CRx WG in bilateral fixation and anatomical alignment tests, demonstrating equivalent fracture fixation and alignment through pendant range of motion. Fixation verification tests measured tensile force required to distract fracture fragments by >2mm, confirming equivalence.

Technological Characteristics

Material: 316L stainless steel. Dimensions: 4 & 5mm OD, 90-120mm length. Design: Intramedullary rod with internal grippers and compression screw. Testing standards: ASTM F1264-03. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with acute clavicle fractures, mal-unions, or non-unions requiring intramedullary fixation.

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 CMx Clavicle Pin (K081832)
• DePuy Rockwood Clavicle Pin (K991649)

Submission Summary (Full Text)

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K100112

# 510(k) Summary

Submitter's name

Phone Number Fax Number

Name of contact person

Date summary was prepared

Proprietarv name/Trade name

Common Name

Classification Name

Predicate Devices

Description of device

Intended use of device

Comparison to Predicate Devi ces

Performance Data (Non clinical)

Sonoma Orthopedic Products, Inc. Santa Rosa, CA 95403 707-526-1335 ext 255 707-540-6001

Carlos Gonzalez

September 28, 2010

Sonoma CWG Clavicle Fracture Repair Device

Intramedullary Fixation Device

888.3020 Intramedullary fixation rod.

Sonoma Orthopedics CMx Clavicle Pin (K081832) DePuy Rockwood Clavicle Pin (K991649)

Sonoma CWG devices are 316L SS intramedullary fixation devices that utilize internal grippers for fixation, similar to the Sonoma CMx predicate and al so use a compression screw similar to the predicate Rockwood pin, to compress the fracture. The device is available in 4 & 5mm OD and sizes 90-120mm in length.

The Sonoma CWG Clavicle Fracture Repair device is intended to be used to repair an acute fracture, mal-union or non-unio n of the clavicle.

The Sonoma CWG Fracture repair device utilizes the same materials and similar construction as the predicate Sonoma CMx Clavicle pin (2 grippers, a wavy body and a straight section to carry the biomechanical load). The CWG does not include a crossscrew (as the predicate CMx) but rather includes a compression screw, similar to the DePuy Rockwood pin to compress the fracture fragments together.

The "working" components of the Sonoma CWG are equivalent to the Sonoma predicate CMx when evaluated against ASTM F1264-03, see the list below. Clinical evaluation of the device is not required .

SEP 28 2010

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## 510(k) Summary of Non-clinical Performance Data Specifically Conducted for Sonoma CRx CWG

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### Tests to ASTM F1264-008

An analysis of the Sonoma CRx CWG design versus the Sonoma CRx WG was conducted for static bending, torque, and cyclic bending fatigue test. The results are described in test report DVR 003-0035. This analysis demonstrates the subject device Sonoma CRx CWG is equivalent to the predicate device Sonoma CRx WG.

#### In-Vitro Cyclic Fatigue Test

Sonoma Orthopedic Products, Inc created a proprietary test that simulates representative biomechanical loading. These data demonstrated the subject design, Sonoma CRx CWG, is equivalent to the predicate device, Sonoma CRx WG. Data are included in TR 003-0031.

#### Indications for Use Test

Comparative, bilateral fixation and anatomical alignment tests were performed in cadaveric torso specimens with the Sonoma CRx WG in one clavicle and the Sonoma CRx CWG in the opposite clavicle. These data demonstrated substantial equivalence to the predicated device, Sonoma CRx WG, for fracture fixation and anatomical alignment through pendant range of motion of the affected appendage. Data are included in DVR 003-0042.

#### Fixation Verification Test

The cadaveric clavicle bone samples as implanted in the Indications for Use Tests (above) were explanted and the opposing tensile force to distract the fracture greater than 2 millimeters was measured. These data demonstrated the subject design, Sonoma CRx CWG, is equivalent to the predicate device. Sonoma CRx WG. Data are included in TR 003-0037.

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

Sonoma Orthopedic Products, Inc. % Mr. Carlos Gonzalez 650 Larkfield Center, Suite C Santa Rosa, CA 95403

SEP 2 8 2010

Re: K100112

Trade/Device Name: Sonoma CWG Clavicle Fracture Repair Device Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 17, 2010 Received: September 20, 2010

Dear Mr. Gonzalez:

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. Ilsting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. Carlos Gonzalez

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/default.htm.

Sincerely yours.

Sincerely yours,

Mark A. Wilkerson

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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# Indications for Use

510(k) Number (if known): _K100112

Device Name: Sonoma CWG Clavicle Fracture Repair Device

SEP 2 8 2010

#### INDICATIONS FOR USE

The Sonoma CWG Clavicle fracture repair device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100112