MIS Bunion System

K181872 · Crossroads Extremity Systems, LLC · HRS · Feb 19, 2019 · Orthopedic

Device Facts

• Record ID: K181872
• Device Name: MIS Bunion System
• Applicant: Crossroads Extremity Systems, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Feb 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

Device Story

MIS Bunion System is a metallic bone fixation implant for hallux valgus correction via minimally invasive surgery. Device consists of a tapered, buttressing implant inserted into the metatarsal intramedullary canal; proximal end features interrupted surfaces for traction/pullout resistance; distal end seats against osteotomy surface and accepts CrossRoads MotoBAND CP screws (K152306) to secure the metatarsal head. System includes specialized instrumentation (osteotomy guide, k-wire, osteotome) and general surgical tools (reamers, drill guide, depth gauge). Implant acts as a buttress to hold the metatarsal head in position during fusion. Used by orthopedic surgeons in clinical settings. Benefits include minimally invasive approach for bone fixation and stabilization of the metatarsal head.

Clinical Evidence

Bench testing only. Evidence includes theoretical cross-sectional analysis of worst-case scenarios and mechanical pull-out testing compared to predicate devices. Pyrogen testing confirmed compliance with endotoxin limits (20 EU/Device).

Technological Characteristics

Implant material: Ti-6Al-4V ELI titanium per ASTM F136. Design: Tapered proximal end with interrupted surfaces for intramedullary fixation; distal end accepts 3.0mm or 3.5mm screws. Mechanical principle: Intramedullary buttress fixation. Non-software device.

Indications for Use

Indicated for patients requiring fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.

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

• CrossTIE Intraosseous Fixation System (K151270)
• In2Bones Kirschner Wires (K153204)

Reference Devices

• CrossRoads MotoBAND CP screw (K152306)

Submission Summary (Full Text)

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CrossRoads Extremity Systems, LLC % Theresa Leister Senior Consultant MRC-X, LLC 6075 Poplar Avenue Memphis, Tennessee 38119

February 19, 2019

## Re: K181872

Trade/Device Name: MIS Bunion 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 Dated: January 22, 2019 Received: January 24, 2019

Dear Ms. Leister:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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.

Jesse Muir -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) K181872

Device Name MIS Bunion System

Indications for Use (Describe)

The MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

| 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

MIS Bunion System February 6, 2019

| Company: | CrossRoads Extremity Systems, LLC<br>6055 Primacy Parkway, Suite 140<br>Memphis, TN 38119 |
|--------------------------------|-------------------------------------------------------------------------------------------|
| Establishment<br>Registration: | 3011421599 |
| Primary Contact: | Theresa Leister<br>Phone: [phone] |
| Company Contact: | Chad Hollis<br>Phone: [phone] |
| Trade Name: | MIS Bunion System |
| Common Name: | Plate, Fixation, Bone |
| Classification: | Class II |

Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)

| Panel: | 87- Orthopedic |
|--------------------|---------------------------------------------------------------------------------------|
| Product Code: | HRS |
| Predicate Devices: | CrossTIE Intraosseous Fixation System (K151270)<br>In2Bones Kirschner Wires (K153204) |

## Device Description:

The CrossRoads MIS Bunion System contains a buttressing implant which can be surgically implanted using a minimally invasive surgical technique to correct hallux valgus. The MIS Bunion implant is to be made of implant grade titanium (Ti-6A1-4V ELI) per ASTM F136 with features allowing it to accept a CrossRoads MotoBAND CP screw (previously cleared in K 152306 ) in the distal end of the implant. Instrumentation required for performing this surgery include a k-wire, for use with an osteotomy guide, and osteotome. Additional general surgical instrumentation utilized include reamers, drill guide, and depth guage. The MIS Bunion implant is tapered on the proximal end so that it can be easily inserted into the intramedullary canal of the metatarsal and the distal head of the implant will seat directly against the osteotomy

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surface. The effect of the MIS Bunion implant being wedged firmly within the intramedullary canal is that it acts as a buttress to hold the metatarsal head in place. To accommodate a range of anatomical sizes and severities of corrections. the implant will be offered in an array of configurations; wherein each incremental size will increase in thickness on the distal end, resulting in different buttressing offsets. The tapered proximal end of the implant will also have interrupted surfaces to gain traction within the cancellous bone, thus resisting pullout. Finally, the MIS bunion implant will accept Ø3.0mm or Ø3.5mm CrossRoads MotoBAND CP screws (K152306) to secure the metatarsal head firmly in place, allowing fusion to occur.

## Indications for Use:

The MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

## Substantial Equivalence:

The subject MIS Bunion System components are substantially equivalent to the following predicate devices:

## Primary Predicate:

CrossTIE Intraosseous Fixation System, K151270

#### Secondary Predicate:

In2Bones Kirschner Wires, K153204

The subject components are similar to the predicate devices in terms of indications, geometry, and materials. Thus. it can be concluded that the subject devices raise no different questions of safety and effectiveness and are substantially equivalent to the predicate devices.

## Performance Testing:

Theoretical analysis was performed utilizing the worst-case cross sections the subject MIS Bunion System. This cross-sectional analysis showed the subject device to be substantially equivalent in terms of performance to the predicate device. Additionally, pull-out testing showed the subject device to be substantially equivalent to the predicate device. Thus, it was determined that no additional mechanical testing is required.

Additionally, pyrogen testing was completed to confirm that the MIS Bunion System meets the endotoxin limit of 20 Endotoxin Units (EU)/Device.

## Conclusion:

There are no substantial differences between the MIS Bunion System and the predicate devices with respect to intended use and technological characteristics, including basic design, materials of manufacture, mechanical properties, and intended effect.

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Therefore, the MIS Bunion System can be found substantially equivalent to the cited predicate, as it does not raise different questions of safety and effectiveness.