MotoBAND CP Implant System

K173710 · Crossroads Extremity Systems, LLC · HWC · Feb 12, 2018 · Orthopedic

Device Facts

• Record ID: K173710
• Device Name: MotoBAND CP Implant System
• Applicant: Crossroads Extremity Systems, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Feb 12, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. When used for these indications, the MotoBAND™ Implant System with the exception of the MTP plates and 2-hole plate may be used with the MotoCLIPTM Implant System.

Device Story

MotoBAND™ CP Implant System consists of metallic bone plates and associated surgical instruments; designed for stabilization and fixation of small bone fractures, joint fusions, and reconstructions. System features various plate geometries, including specific valgus and dorsiflexion angles, and accommodates nitinol clips (MotoCLIP™). Used by orthopedic surgeons in clinical settings; implants are surgically placed to provide mechanical stability to bone segments. Output is physical fixation of bone; aids in healing and structural alignment. Benefits include improved stabilization of small bone anatomy during recovery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and theoretical mechanical analysis comparing the subject device to predicate systems.

Technological Characteristics

Implant components manufactured from titanium alloy (ASTM F136). System includes plates with varying valgus (0°, 5°, 10°) and dorsiflexion (0°, 2.5°, 5°, 7.5°, 10°) geometries. Compatible with nitinol staples. Mechanical fixation device; no energy source or software.

Indications for Use

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

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• MotoBAND™ CP Implant System (K160300)
• MotoBAND™ CP Implant System (K152306)

Submission Summary (Full Text)

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February 12, 2018

CrossRoads Extremity Systems, LLC % Christine Scifert Executive Vice President MRC-X, LLC 6075 Poplar Avenue Memphis. Tennessee 38119

Re: K173710

Trade/Device Name: MotoBANDTM CP Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: January 17, 2018 Received: January 18, 2018

Dear Ms. Scifert:

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 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 (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Katherine D. Kavlock -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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### Indications for Use

510(k) Number (if known)

K173710

Device Name MotoBAND™ 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. When used for these indications, the MotoBAND™ Implant System with the exception of the MTP plates and 2-hole plate may be used with the MotoCLIPTM Implant System.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span></span> </div> |
|----------------------------------------------|----------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span></span> </div> |

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## 510(k) Summary

| Date: | February 8, 2018 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MotoBAND™ CP Implant System |
| Company: | CrossRoads Extremity Systems (previously<br>OrthoDiscovery Group LLC)<br>6055 Primacy Parkway, Suite 140<br>Memphis, TN 38119 USA<br>Phone: [phone] |
| Primary Contact: | Christine Scifert, MS, MEM<br>Executive Vice President<br>MRC-X, LLC<br>901-831-8053<br>[e-mail] |
| Company Contact: | Chad Hollis<br>Vice President of Research & Development<br>CrossRoads Extremity Systems<br>901.221.8406<br>[e-mail] |
| Trade Name: | MotoBAND™ CP Implant System |
| Common Name: | Plate System |
| Classification: | Class II |
| Regulation Number: | 888.3040, Smooth or threaded metallic bone fixation<br>fastener<br>888.3030, Single/multiple component metallic bone<br>fixation appliances and accessories |
| Panel: | Orthopedic |
| Product Code: | HWC, HRS |
| Predicate Devices: | Primary Predicate:<br>K160300 MotoBAND™ CP Implant System |
| | Additional Predicate:<br>K152306 MotoBAND™ CP Implant System |
| Device Description: | The MotoBAND™ CP Implant System is comprised of<br>implant plates and instruments, having various features and<br>sizes to accommodate differing patient anatomy. Plate<br>geometries include valgus options of 0°, 5° and 10°,<br>dorsiflexion options of 0°, 2.5°, 5°, 7.5° and 10° and options<br>to use either a 15mm or 18mm nitinol clip. MotoBAND™<br>CP Implant System is compatible with MotoCLIP™ Staple. |
| Indications for Use: | The MotoBAND™ CP Implant System is indicated for<br>stabilization and fixation of fresh fractures, revision<br>procedures, joint fusion and reconstruction of small bones<br>of the hand, feet, wrist, ankles, fingers and toes. When used<br>for these indications, the MotoBAND™ CP Implant<br>System with the exception of the MPJ plates and 2-hole<br>plate may be used with the MotoCLIP™ Implant System. |
| Materials: | The MotoBAND™ CP Implant System implant components<br>are manufactured titanium alloy (ASTM F136). |
| Substantial Equivalence: | Theoretical analysis of the worst case MotoBAND™ CP<br>Implant System was performed to predict torsional and<br>pullout strengths as well as plate bending strength for the<br>subject and predicate devices (CrossRoads MotoBAND™<br>CP System K152306 and K160300). The results<br>demonstrate the predicted performance of the<br>MotoBAND™ CP Implant System is substantially<br> |
| Performance Testing: | Theoretical analysis of the worst case MotoBAND™ CP<br>Implant System shows that the strength of the subject plates<br>exceeds the strength of the worst-case plate in the predicate<br>system (K152306 and K160300). The results demonstrate |

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the predicted performance of the MotoBAND™ CP Implant System is substantially equivalent to the predicate device.

- The fundamental scientific technology of the MotoBAND™ Conclusion: CP Implant System devices is the same as previously cleared devices. Therefore, the MotoBAND™ CP Implant System is substantially equivalent for its intended use.