MotoCLIP/HiMAX Implant System

K181410 · Crossroads Extremity Systems, LLC · JDR · Jun 29, 2018 · Orthopedic

Device Facts

• Record ID: K181410
• Device Name: MotoCLIP/HiMAX Implant System
• Applicant: Crossroads Extremity Systems, LLC
• Product Code: JDR · Orthopedic
• Decision Date: Jun 29, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MotoCLIP™HiMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

Device Story

The MotoCLIP/HiMAX Implant System is a metallic bone staple system used by orthopedic surgeons for fixation of bone fractures, fusions, and osteotomies in the hand and foot. The system consists of Nitinol implants and associated surgical instrumentation. It functions as a line extension of the previously cleared CrossCLIP system, featuring modified implant and instrument geometry. The device provides mechanical stabilization of bone fragments to facilitate healing. Surgeons select and implant the staples during reconstructive or fracture surgery. Performance is verified through engineering analysis and mechanical pull-out testing to ensure strength characteristics meet or exceed those of the predicate device.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including theoretical Finite Element Analysis (FEA) to predict compression force and maximum strain, and mechanical pull-out testing comparing the subject device to the predicate.

Technological Characteristics

Metallic bone staple system; material: Nitinol (ASTM F2063); includes implants and surgical instrumentation; mechanical fixation principle; non-software device.

Indications for Use

Indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis in patients requiring bone fixation for fractures, fusions, or osteotomies.

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

• CrossCLIP™ Implants (K142727)

Submission Summary (Full Text)

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CrossRoads Extremity Systems, LLC % Christine Seifert Executive Vice President MRC/X, LLC 6075 Poplar Avenue Memphis, Tennessee 38119

June 29, 2018

Re: K181410

Trade/Device Name: MotoCLIP/HiMAX 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: JDR Dated: May 25, 2018 Received: May 30, 2018

Dear Christine Seifert:

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

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 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,

# 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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# Indications for Use

510(k) Number (if known) K181410

Device Name MotoCLIP/HiMAX™ Implant System

Indications for Use (Describe)

The MotoCLIP™HiMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

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)

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### 510(k) Summary

MotoCLIP™/HiMAX™ Implant System June 24, 2018

| Company: | CrossRoads Extremity Systems, LLC<br>6055 Primacy Parkway, Suite 140<br>Memphis, TN 38119 |
|--------------------------------|--------------------------------------------------------------------------------------------------|
| Establishment<br>Registration: | 3011421599 |
| Primary Contact: | Christine Scifert<br>Phone: [phone] |
| Company Contact: | Chad Hollis<br>Phone: [phone] |
| Trade Name: | MotoCLIP™/HiMAX™ Implant System |
| Common Name: | Staple, Fixation, Bone |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3030 (Single/multiple component metallic bone fixation<br>appliances and accessories) |
| Panel: | 87- Orthopedic |
| Product Code: | JDR |
| Predicate Devices: | CrossRoads Extremity Systems, LLC CrossCLIP™ Implants (K142727) |

## Device Description:

MotoCLIP™/HiMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the management of bone fractures and reconstruction surgery. The MotoCLIP™/HiMAXIM Implant System is a line extension of the previously cleared CrossCLIP™ System K142727. After clearance, CrossRoads re-branded the CrossCLIP™ System to the MotoCLIPTMTM Implant System.

The MotoCLIP™/HiMAX™ Implant System gives the surgeon a means for fixation of fractures, fusions, and osteotomies of the foot, ankle, and hand. The MotoCLIP™/HiMAX™ Implant System includes implants and the related instrumentation needed for implantation. The implants are made from implant grade Nitinol per ASTM F2063.

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The only modifications being made in this submission are changes in the geometry of the implants and associated instruments.

## Indications for Use:

The MotoCLIP™HiMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

## Substantial Equivalence:

The subject MotoCLIP™/HiMAX™ Implant Sytem is substantially equivalent to CrossRoads Extremities Systems, LLC's previously cleared CrossCLIP™ Implant (K142727).

There are no substantial differences between the MotoCLIP™HiMAX™ Implant System and the predicate CrossCLIP™ Implants (now branded MotoCLIP™/HiMAX™ Implant System) with respect to intended use and technological characteristics. including basic design, materials of manufacture, mechanical properties, and intended effect.

The minor modification that is the subject of this submission is that the geometry of the subject implants vary from the predicate implants. Engineering analysis shows that the performance of the implants meets or exceeds the strength of the worst-case implant in the previously cleared system (K142727).

Therefore, the MotoCLIP™HiMAX™ Implant System can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.

# Performance Testing:

Theoretical analysis (FEA) of the worst case MotoCLIP™/HiMAX™ Implant System was performed to predict compression force as well as maximum strain for the subject and predicate devices. In addition, pull-out testing was performed to compare the predicate to the subject device. The results of the theoretical analysis and pull-out testing demonstrate the predicted performance of the subject MotoCLIP™/HiMAX™ Implant System does not introduce a new worst case and therefore is substantially equivalent to the predicate devices.

# Conclusion:

There are no substantial differences between the MotoCLIP™/HiMAX™ Implant System and the predicate CrossCLIP™ Implants (now branded MotoCLIP™/HiMAX™ Implant System) with respect to intended use and technological characteristics, including basic design, materials of manufacture, mechanical properties, and intended effect.

Therefore, the MotoCLIP™/HiMAX™ Implant System can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.