SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)

K111550 · Sonoma Orthopedic Products, Inc. · HSB · Aug 19, 2011 · Orthopedic

Device Facts

• Record ID: K111550
• Device Name: SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
• Applicant: Sonoma Orthopedic Products, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sonoma FasTrac 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 FasTrac is an intramedullary fixation device for clavicle fracture repair. Constructed from Ti-6Al-4V titanium or 316L stainless steel, the device features a central rod with threads for fixation and a hub with a cross screw or compression screw on the opposite end. Available in nominal diameters of 3-6mm and lengths of 70-150mm. Used by orthopedic surgeons in a clinical/surgical setting to stabilize clavicle fractures, mal-unions, or non-unions. The device is inserted into the intramedullary canal; threads and screws provide mechanical fixation to maintain alignment and promote healing. Benefits include structural stability equivalent to predicate intramedullary rods, facilitating bone repair.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including dynamic compression, bending, torsion, and cyclic fatigue testing performed in accordance with ASTM F1264-03.

Technological Characteristics

Materials: Ti-6Al-4V Titanium or 316L Stainless Steel. Design: Intramedullary fixation rod with threads and cross/compression screws. Dimensions: 3-6mm OD, 70-150mm length. Standards: ASTM F1264-03. Mechanical principle: Intramedullary fixation via threaded engagement and screw compression.

Indications for Use

Indicated for patients requiring repair of acute clavicle fractures, mal-unions, or non-unions.

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 Orthopedic Products, Inc. EnsplintCMX (K081832)
• Depuy Rockwood Pin (K991649)

Submission Summary (Full Text)

{0}------------------------------------------------

( 114)

## 510(k) Summary

Submitter's name Address

Phone Number Fax Number Name of contact person Date summary was prepared

Proprietary name/Trade name

Common Name

Classification Name

Predicate Device

Description of device

Intended use of device

Comparison to Predicate Device

Performance Data (Non clinical)

K11550

Sonoma Orthopedic Products, Inc. AUG 1 9 2011 3589 Westwind Blvd. Santa Rosa, CA 95403 707-526-1335 707-526-2022 Charles L. Nelson June 30, 2011 Sonoma FasTrac Clavicle Fracture Repair Device Clavicle Pin 888.3020 Intramedullary fixation rod. Sonoma Orthopedic Products, Inc. K081832, EnsplintCMX, Depuy Rockwood Pin K991649 The Sonoma FasTrac Clavicle Fracture Repair Devices are stainless steel or titanium intramedullary fixation devices that utilize threads for fixation and a hub with cross screw. The device is available in nominal 3, 4, 5, and 6mm nominal OD and sizes 70-150mm nominal lengths. The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle. The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be made of Ti-6Al-4V Titanium or 316L Stainless Steel. The Sonoma Orthopedic Products, Inc. K081832, CMX and Depuy Rockwood Pin K991649 are also made of stainless steel. The Sonoma FasTrac device achieved equivalent strength and fatique performance to the predicate devices. The FasTrac device is secured in place with threads on one end and a cross screw or compression screw on the opposite end. The Sonoma FasTrac meets the mechanical requirements of ASTM F1264-03. The Sonoma FasTrac Clavicle Fracture Repair Device is equivalent to the predicate devices. the Sonoma Orthopedic Products, Inc. K081832, CMX and Depuy Rockwood Pin K991649. This determination was made from empirical testing and engineering analysis. Attached is the summary table of Performance Testing. Clinical evaluation of the device is not required.

{1}------------------------------------------------

| Test | Applicable<br>Standard | Protocol/Report<br>Number<br>(Sonoma<br>Fastrac) | Protocol/Report<br>Number (Rockwood<br>Pin and/or Ensplint<br>CMx) | Conclusion | Equivalent |
|---------------------------------------------|------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Dynamic Compression,<br>Bending and Torsion | N/A | DVP-003-0046<br>DVR-003-0046 | DVP/DVR-003-0013 | The Sonoma FasTrac<br>is substantially<br>equivalent to the<br>Ensplint CMx under<br>compressive, bending<br>and torsional loads in<br>a simulated in-vivo<br>environment with<br>respect to the<br>biomechanical loads. | Equivalent |
| Cyclic Bending Fatigue | ASTM F1264-<br>03(07) | DVP-003-0044<br>DVR-003-0044 | DVP/DVR-003-0002<br>DVP/DVR-003-0021 | The bending fatigue<br>properties of the<br>predicate Depuy<br>Rockwood Pin and the-<br>Sonoma FasTrac are<br>substantially<br>equivalent when tested<br>under similar loading. | Equivalent |
| Static Bending | ASTM F1264-<br>03(07) | DVP-003-0044<br>DVR-003-0044 | DVP/DVR-003-0001<br>DVP/DVR-003-0022<br>TR-003-0009<br>TR-003-0018 | The bending<br>properties of the<br>predicate Depuy<br>Rockwood Pin and the<br>Sonoma FasTrac are<br>substantially<br>equivalent when tested<br>under similar loading. | Equivalent |
| Static Torsion | ASTM F1264-<br>03(07) | DVP-003-0044<br>DVR-003-0044 | DVR-003-0008 | | |
| | | | The static torsional<br>stiffness properties of<br>the predicate device<br>and the Sonoma<br>FasTrac are<br>substantially<br>equivalent when tested<br>under similar loading. | Equivalent | |
| Indications for Use | N/A | None | DVP/DVR-003-0010 | The Sonoma Fastrac<br>is equivalent in size,<br>configuration and<br>fixation methods to the<br>predicate devices and<br>therefore<br>demonstrates<br>equivalent fixation and<br>alignment properties. | Equivalent |

Performance Testing Summar

.

{2}------------------------------------------------

・・

ﺰ

.

:

{3}------------------------------------------------

Page intentionally left blank

.

KIIISSO14/4)

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the perimeter. Inside the seal is a stylized symbol that resembles three overlapping human figures or abstract shapes. The image is in black and white.

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

Sonoma Orthopedic Products. Inc. % Mr. Charles L. Nelson Chief Operating Officer 3589 Westwind Boulevard Santa Rosa, California 95403

AUG 19 2011

Re: K111550

Trade/Device Name: Sonoma FasTrac Clavicle Fracture Repair Device Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 28, 2011 Received: June 29, 2011

Dear Mr. Nelson:

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

{5}------------------------------------------------

Page 2 - Mr. Charles L. Nelson

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 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.html 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/Reportal?roblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Millman

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

Enclosure

{6}------------------------------------------------

Page 8/54
KIIISSO

## Indications for Use

510(k) Number (if known): K111550

Device Name: Sonoma FasTrac Clavicle Fracture Repair Device

INDICATIONS FOR USE

The Sonoma FasTrac 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)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Ar m.Mellerm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111550