MotoBand¿ CP Implant System

K152306 · Crossroads Extremity Systems, LLC · HRS · Dec 11, 2015 · Orthopedic

Device Facts

• Record ID: K152306
• Device Name: MotoBand¿ CP Implant System
• Applicant: Crossroads Extremity Systems, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Dec 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MotoBAND™ CP Implant System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

Device Story

MotoBand CP Implant System consists of metallic bone plates and screws; used for stabilization/fixation of small bone fractures, revisions, joint fusions, and reconstructions in extremities (hand, feet, wrist, ankles, fingers, toes). System includes various plate geometries (double Y, Y-plate, straight, MTP). Operated by surgeons in clinical settings. Provides mechanical stabilization of bone segments to facilitate healing. Benefit: restoration of skeletal alignment and stability.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by theoretical analysis comparing torsional, pullout, and plate bending strengths of subject device against predicate devices.

Technological Characteristics

Metallic bone fixation system. Materials: Titanium alloy (ASTM F136). Components: Plates (double Y, Y-plate, straight, MTP) and bone screws. Mechanical properties and stabilization method are equivalent to predicate systems.

Indications for Use

Indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hand, feet, wrist, ankles, fingers, and toes.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• ANCHORAGE™ CP (K083447)
• Flower Small and Medium Implant Set (K131657)
• Flower Small and Medium Implant Set (K123562)

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

December 11, 2015

CrossRoads Extremity Systems, LLC Mr. Vernon Hartdegen Sr. Vice President of Operations 6055 Primacy Pkwy, Suite 140 Memphis, Tennessee 38119

Re: K152306 Trade/Device Name: MotoBand™ CP Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 21, 2015 Received: October 26, 2015

Dear Mr. Hartdegen:

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 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 | |
| <b>Indications for Use</b> | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. | |

| 510(k) Number (if known) | K152306 (page 1 of 1) |
|--------------------------|-----------------------|
|--------------------------|-----------------------|

| Device Name |
|------------------------------------------|
| MotoBand ^TM CP Implant System |

Indications for Use (Describe)

The MotoBand™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

| Date: | October 21, 2015 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MotoBAND™ CP Implant System |
| Company: | CrossRoads Extremity Systems<br>(previously OrthoDiscovery Group LLC)<br>6055 Primacy Parkway, Suite 140<br>Memphis, TN 38119 USA<br>Phone: [phone] |
| Primary Contact: | Vernon Hartdegen, Sr. VP of Operations<br>901.221.8406<br>[e-mail] |
| Trade Name: | MotoBAND™ CP Implant System |
| Common Name: | Plate System |
| Classification: | Class II |
| Regulation Number: | 888.3030 Single/multiple component metallic bone fixation<br>appliances and accessories<br>888.3040, Smooth or threaded metallic bone fixation fastener |
| Panel: | Orthopedic |
| Product Code: | HRS, HWC |
| Predicate Devices: | K083447 ANCHORAGE™ CP<br>K131657 and K123562 Flower Small and Medium Implant Set |
| Device Description: | The MotoBAND™ CP Implant System is comprised of implant<br>plates, bone screws and instruments, having various features and<br>sizes to accommodate differing patient anatomy. Plate geometries<br>include the double Y plate, Y-plate, straight plate (2 hole, 4 hole<br>and 5 hole) and MTP plate with 10° Valgus, 0° Dorsi-Flexion. |
| Indications for Use: | The MotoBAND™ CP Implant System is indicated for stabilization<br>and fixation of fresh fractures, revision procedures, joint fusion<br>and reconstruction of small bones of the hand, feet, wrist, ankles,<br>fingers and toes. |
| Materials: | The MotoBAND™ CP Implant System implant components are<br>manufactured titanium alloy (ASTM F136). |
| Substantial Equivalence: | Theoretical analysis of the worst case MotoBAND™ CP Implant<br>System was performed to predict torsional and pullout strengths as<br>well as plate bending strength for the subject and predicate<br>devices (Flower Orthopedic plates (K131657 and K123562)<br>ANCHORAGE™ CP (K083447) plates). The results demonstrate<br>the predicted performance of the MotoBAND™ CP Implant System<br>is substantially equivalent to the predicate devices. There are no<br>substantive differences between the MotoBAND™ CP Implant<br>System and the cited predicates with respect to intended use and<br>technological characteristics. The MotoBAND™ CP Implant<br>System possesses the same technological characteristics as the<br>predicate devices, including:<br>• Predicted performance and method of stabilization,<br>• Materials of manufacture,<br>• Basic design, and<br>• Mechanical properties.<br>Therefore, the fundamental scientific technology of the<br>MotoBAND™ CP Implant System devices is the same as<br>previously cleared devices. Therefore the MotoBAND™ CP<br>Implant System is substantially equivalent for its intended use. |
| Performance Testing: | Theoretical analysis of the worst case MotoBAND™ CP Implant<br>System was performed to predict torsional and pullout strengths as<br>well as plate bending strength for the subject and predicate<br>devices. The results demonstrate the predicted performance of the<br>MotoBAND™ CP Implant System is substantially equivalent to the<br>predicate device |

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Image /page/4/Picture/1 description: The image shows the logo for Crossroads Extremity Systems. The logo consists of a grid of four squares in the colors blue and green, followed by the word "CrossRoads" in gray, with a trademark symbol next to it. Below the word "CrossRoads" is the text "Extremity Systems" in a smaller, lighter gray font.