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.

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

AI/ML Overview

This document describes the MotoCLIP™/HiMAX™ Implant System, which is a staple system for bone fixation in hand and foot osteotomy and joint arthrodesis. The submission is a line extension of the previously cleared CrossCLIP™ System (K142727).

Here's a breakdown of the acceptance criteria and study information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabulated format with numerical targets. Instead, the performance evaluations are centered around demonstrating substantial equivalence to a predicate device (CrossCLIP™ Implants, K142727). The core acceptance is that the device does not introduce a new worst case and meets or exceeds the strength of the worst-case implant in the previously cleared system.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: Does not introduce a new worst case.	Theoretical analysis (FEA) of the worst-case MotoCLIP™/HiMAX™ Implant System predicts compression force and maximum strain. These results, along with pull-out testing, demonstrate that the subject device's predicted performance does not introduce a new worst case compared to the predicate device. The engineering analysis also shows that the performance of the implants meets or exceeds the strength of the worst-case implant in the previously cleared system (K142727).
Material Equivalence: Same materials as predicate.	The implants are made from implant grade Nitinol per ASTM F2063, which is the same material used in the predicate.
Intended Use Equivalence: Same indications for use.	The MotoCLIP™/HiMAX™ Implant System has the same indications for use as the predicate: "hand and foot bone fragment osteotomy fixation and joint arthrodesis."
Technological Equivalence: Similar basic design and function.	The document states, "There are no substantial differences between the MotoCLIP™/HiMAX™ Implant Sytem and the predicate CrossCLIP™ Implants... with respect to intended use and technological characteristics, including basic design, materials of manufacture, mechanical properties, and intended effect." The only modification is geometry.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified for the theoretical analysis (FEA) or pull-out testing. The description only refers to "worst case" analysis and "the subject device."
Data Provenance: Not specified. It's an engineering analysis and bench testing, likely conducted internally by the manufacturer or a contracted lab. There's no mention of patient data (retrospective or prospective) for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission concerns a mechanical device (bone fixation staple). The "ground truth" for its performance is established through biomechanical testing and engineering analysis, not expert clinical interpretation of images or patient outcomes.

4. Adjudication method for the test set

Not applicable, as this is a mechanical performance study, not a clinical study involving human judgment or interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (implantable staple), not an AI/imaging diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence and acceptable performance for this device is based on bench testing and theoretical engineering analysis (FEA), specifically:

Predicted compression force
Maximum strain
Pull-out strength

These are compared against the known performance characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This is not a study involving machine learning or statistical modeling that would require a "training set." The data comes from engineering simulations and physical bench tests.

9. How the ground truth for the training set was established

Not applicable, for the same reasons as #8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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, LLC6055 Primacy Parkway, Suite 140Memphis, TN 38119
EstablishmentRegistration:	3011421599
Primary Contact:	Christine ScifertPhone: 901-831-8053
Company Contact:	Chad HollisPhone: 901-221-8406
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 fixationappliances and accessories)
Panel:	87- Orthopedic
Product Code:	JDR
Predicate Devices:	CrossRoads Extremity Systems, LLC CrossCLIP™ Implants (K142727)

Device Description:

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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.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.