(28 days)
No
The summary describes a mechanical implant system and its components, with performance studies focused on engineering analysis and mechanical properties. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is an implant system used for fixation of fractures and reconstruction of bones in the hand, feet, wrist, ankles, fingers and toes, which are therapeutic interventions.
No
The device is described as an "Implant System" for "fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones". This indicates its purpose is therapeutic (treatment/reconstruction), not diagnostic.
No
The device description explicitly states it is comprised of "implant plates and instruments," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones...". This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details implant plates, screws, and clips made of materials like nitinol. These are physical components designed to be surgically implanted.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided describes a surgical implant system, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for 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 2-hole plate may be used with the MotoCLIP™ HiMAX™ Implant System.
Product codes
HRS, HWC, JDR
Device Description
The subject MotoBAND CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries are 5° valgus and have options of 0°,5°, and 10° dorsiflexion and can be used with 18mm, 20mm or 25mm nitinol clip. Non-locking and poly-axial locking screws are included in the system: 3.0mm diameter and 3.5mm diameters in lengths of 10-50 mm. MotoBAND CP Implant System is compatible with MotoCLIP/HiMAX Clips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand, feet, wrist, ankles, fingers and toes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Engineering analysis of the worst case MotoBAND™ CP Implant System was performed to compare component performance for the subject and predicate devices. Changes to the subject devices include 1. longer bridge length clips (20mm and 25mm) 2. longer length screws (32-50mm) and 3. plate geometry modification for clip compatibility. The maximum plate length decreased; the thickness and width are similar to the predicate plate. The results demonstrate the predicted performance of the MotoBAND™ CP Implant System with MotoCLIP™/HIMAX™ Implant System is substantially equivalent to the predicate devices. There are no substantive differences between the MotoBAND™ CP Implant System and the cited predicates with respect to intended use and technological characteristics. The MotoBAND™ CP Implant System possesses the same technological characteristics as the predicate devices, including:
- Predicted performance and method of stabilization,
- . Materials of manufacture,
- . Basic design, and
- . Mechanical properties.
Performance Testing: Engineering analysis of the worst case MotoBAND CP Implant Svstem with MotoCLIP™/HIMAX™ Implant System shows that the strength of the plates, staple bending strength and bending stiffness and staple/screw fixation performance exceeds the strength of the worst-case implants in the predicate system. No additional mechanical testing is required. The results demonstrate the performance of the subject MotoBAND CP Implant System is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K173710 MotoBAND CP Implant System
Reference Device(s)
K181410 MotoCLIP™/HiMAX™ Implant System
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
January 10, 2020
CrossRoads Extemity Systems, LLC Kim Strohkirch Sr. Director, OA/RA 6055 Primacy Pkwy, Suite 140 Memphis. Tennessee 38119
Re: K193452
Trade/Device Name: MotoBAND CP 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: HRS, HWC, JDR Dated: December 12, 2019 Received: December 13, 2019
Dear Kim Strohkirch:
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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K193452
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 2-hole plate may be used with the MotoCLIP™ HiMAX™ Implant System.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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Image /page/3/Picture/2 description: The image shows the logo for "CrossRoads Extremity Systems". The logo consists of four squares in the colors blue and green, followed by the company name in gray. The word "CrossRoads" is in a larger font than "Extremity Systems", and there is a trademark symbol next to the word "CrossRoads".
| 510(k) Summary | |
|---|---|
| Date: | January 9, 2019 |
| Device Name: | MotoBAND™ CP Implant System |
| Establishment | |
| Registration: | 3011421599 |
| Company: | CrossRoads Extremity Systems |
| 6055 Primacy Parkway, Suite 140 | |
| Memphis, TN 38119 USA | |
| Contact Person: | Kim Strohkirch |
| Sr. Director, QA/RA | |
| CrossRoads Extremity Systems | |
| 901.221.8406 | |
| kstrohkirch@crextremity.com | |
| Trade Name: | MotoBAND CP Implant System |
| Common Name: | Plate, Fixation, Bone |
| Classification: | Class II |
| Regulation Number: | 888.3030 Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Panel: | Orthopedic |
| Product Code: | HRS |
| HWC | |
| JDR | |
| Predicate Devices: | Primary Predicate: |
| K173710 MotoBAND CP Implant System | |
| Additional Predicate: | |
| K181410 MotoCLIP™/HiMAX™ Implant System | |
| Device Description: | The subject MotoBAND CP Implant System is comprised |
| of implant plates and instruments, having various features | |
| and sizes to accommodate differing patient anatomy. | |
| Plate geometries are 5° valgus and have options of 0°,5°, | |
| and 10° dorsiflexion and can be used with 18mm, 20mm or | |
| 25mm nitinol clip. Non-locking and poly-axial locking | |
| screws are included in the system: 3.0mm diameter and | |
| 3.5mm diameters in lengths of 10-50 mm. MotoBAND CP | |
| Implant System is compatible with MotoCLIP/HiMAX Clips. |
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Image /page/4/Picture/2 description: The image shows the logo for CrossRoads Extremity Systems. The logo consists of a series of four squares in the colors blue and green, followed by the word "CrossRoads" in gray. Below the word "CrossRoads" is the phrase "Extremity Systems" in a smaller, lighter gray font.
- The MotoBAND™ CP Implant System is indicated for Indications for Use: stabilization 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 2-hole plate, may be used with the MotoCLIP™/HiMAX™ Implant System.
Materials: The MotoBAND CP Implant System implant components are manufactured from titanium alloy (ASTM F136). MotoCLIP™/HIMAX™ Implant System is composed of nitinol.
Substantial Equivalence: Engineering analysis of the worst case MotoBAND™ CP Implant System was performed to compare component performance for the subject and predicate devices. Changes to the subject devices include 1. longer bridge length clips (20mm and 25mm) 2. longer length screws (32-50mm) and 3. plate geometry modification for clip compatibility. The maximum plate length decreased; the thickness and width are similar to the predicate plate. The results demonstrate the predicted performance of the MotoBAND™ CP Implant System with MotoCLIP™/HIMAX™ Implant System is substantially equivalent to the predicate devices. There are no substantive differences between the MotoBAND™ CP Implant System and the cited predicates with respect to intended use and technological characteristics. The MotoBAND™ CP Implant System possesses the same technological characteristics as the predicate devices, including:
- Predicted performance and method of stabilization,
- . Materials of manufacture,
- . Basic design, and
- . Mechanical properties.
Performance Testing: Engineering analysis of the worst case MotoBAND CP Implant Svstem with MotoCLIP™/HIMAX™ Implant System shows that the strength of the plates, staple bending strength and bending stiffness and staple/screw fixation performance exceeds the strength of the worst-case implants in the predicate system. No additional mechanical testing is required. The results demonstrate the performance of the subject MotoBAND CP Implant System is substantially equivalent to the predicate device.
- Conclusion: There are no substantial differences between the MotoBAND CP Implant System and the predicate devices with respect to intended use and technological characteristics, including
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Image /page/5/Picture/2 description: The image shows the logo for "CrossRoads Extremity Systems". The logo consists of a grid of four squares in the colors blue and green, followed by the text "CrossRoads" in a gray sans-serif font. Below the text "CrossRoads" is the text "Extremity Systems" in a smaller, lighter gray font. The logo is clean and modern, and the colors are bright and eye-catching.
basic design, materials of manufacture, mechanical properties, and intended effect.
Therefore, the MotoBAND CP Implant System can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.