(222 days)
No
The device description and performance studies focus on the mechanical properties and surgical implantation of a bone plate system, with no mention of AI or ML technologies.
Yes
The device is described as an implantable system for the fixation of osteotomies and corrective procedures for hallux valgus, directly contributing to the treatment and healing of a medical condition.
No
The device is described as an implantable system for fixation of osteotomies and corrective procedures, not for diagnosis.
No
The device description clearly details a physical implant made of titanium and associated surgical instrumentation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus." This describes a surgical procedure performed on a patient's body.
- Device Description: The device is described as a "buttressing implant which can be surgically implanted." This is an implantable medical device used in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo to provide structural support and fixation within the body.
N/A
Intended Use / 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.
Product codes
HRS
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hallux
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Endotoxin limit of 20 Endotoxin Units (EU)/Device
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
6055 Primacy Parkway, Suite 140
Memphis, TN 38119 |
|--------------------------------|-------------------------------------------------------------------------------------------|
| Establishment
Registration: | 3011421599 |
| Primary Contact: | Theresa Leister
Phone: 901-489-1715 |
| Company Contact: | Chad Hollis
Phone: 901-221-8406 |
| 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) |
| 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
4
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.