(119 days)
Not Found
No
The document describes a mechanical implant system and its components, with no mention of software, algorithms, or any features suggestive of AI/ML.
Yes
The device is an implant system used for fixation of fractures, joint fusion, and reconstruction, which are therapeutic procedures aimed at healing or modifying the body to improve health.
No
Explanation: The device is described as an implant system used for fixation and reconstruction of bones, not for diagnosing medical conditions.
No
The device description explicitly states it is comprised of implant plates, bone screws, and instruments, which are physical hardware components.
Based on the provided information, the MotoBand™ CP Implant System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "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, bone screws, and instruments, which are all components of a surgical implant system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVDs are used to perform tests on samples taken from the body, while this device is implanted directly into the body.
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.
Product codes
HRS, HWC
Device Description
The MotoBAND™ CP Implant System is comprised of implant plates, bone screws and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries include the double Y plate, Y-plate, straight plate (2 hole, 4 hole and 5 hole) and MTP plate with 10° Valgus, 0° Dorsi-Flexion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
hand, feet, wrist, ankles, fingers and toes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Theoretical analysis of the worst case MotoBAND™ CP Implant System was performed to predict torsional and pullout strengths as well as plate bending strength for the subject and predicate devices. The results demonstrate the predicted performance of the MotoBAND™ CP Implant System is substantially equivalent to the predicate device
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 11, 2015
CrossRoads Extremity Systems, LLC Mr. Vernon Hartdegen Sr. Vice President of Operations 6055 Primacy Pkwy, Suite 140 Memphis, Tennessee 38119
Re: K152306 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 Dated: October 21, 2015 Received: October 26, 2015
Dear Mr. Hartdegen:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K152306 (page 1 of 1) |
|---|---|
| -------------------------- | ----------------------- |
| Device Name |
|---|
| MotoBand TM 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
| Date: | October 21, 2015 |
|---|---|
| Device Name: | MotoBAND™ CP Implant System |
| Company: | CrossRoads Extremity Systems |
| (previously OrthoDiscovery Group LLC) | |
| 6055 Primacy Parkway, Suite 140 | |
| Memphis, TN 38119 USA | |
| Phone: 901.221.8406 | |
| Primary Contact: | Vernon Hartdegen, Sr. VP of Operations |
| 901.221.8406 | |
| Vhartdegen@crextremity.com | |
| Trade Name: | MotoBAND™ CP Implant System |
| Common Name: | Plate System |
| Classification: | Class II |
| Regulation Number: | 888.3030 Single/multiple component metallic bone fixation |
| appliances and accessories | |
| 888.3040, Smooth or threaded metallic bone fixation fastener | |
| Panel: | Orthopedic |
| Product Code: | HRS, HWC |
| Predicate Devices: | K083447 ANCHORAGE™ CP |
| K131657 and K123562 Flower Small and Medium Implant Set | |
| Device Description: | The MotoBAND™ CP Implant System is comprised of implant |
| plates, bone screws and instruments, having various features and | |
| sizes to accommodate differing patient anatomy. Plate geometries | |
| include the double Y plate, Y-plate, straight plate (2 hole, 4 hole | |
| and 5 hole) and MTP plate with 10° Valgus, 0° Dorsi-Flexion. | |
| Indications for Use: | The MotoBAND™ CP Implant System is indicated for stabilization |
| and fixation of fresh fractures, revision procedures, joint fusion | |
| and reconstruction of small bones of the hand, feet, wrist, ankles, | |
| fingers and toes. | |
| Materials: | The MotoBAND™ CP Implant System implant components are |
| manufactured titanium alloy (ASTM F136). | |
| Substantial Equivalence: | Theoretical analysis of the worst case MotoBAND™ CP Implant |
| System was performed to predict torsional and pullout strengths as | |
| well as plate bending strength for the subject and predicate | |
| devices (Flower Orthopedic plates (K131657 and K123562) | |
| ANCHORAGE™ CP (K083447) plates). The results demonstrate | |
| the predicted performance of the MotoBAND™ CP 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. | |
| Therefore, the fundamental scientific technology of the | |
| MotoBAND™ CP Implant System devices is the same as | |
| previously cleared devices. Therefore the MotoBAND™ CP | |
| Implant System is substantially equivalent for its intended use. | |
| Performance Testing: | Theoretical analysis of the worst case MotoBAND™ CP Implant |
| System was performed to predict torsional and pullout strengths as | |
| well as plate bending strength for the subject and predicate | |
| devices. The results demonstrate the predicted performance of the | |
| MotoBAND™ CP Implant System is substantially equivalent to the | |
| predicate device |
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Image /page/4/Picture/1 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 word "CrossRoads" in gray, with a trademark symbol next to it. Below the word "CrossRoads" is the text "Extremity Systems" in a smaller, lighter gray font.