(78 days)
No
The summary describes a system of implants and instruments for bone fixation and reconstruction, with no mention of AI or ML technology. The performance studies focus on material properties and fatigue testing.
No
The device is described as an implant system for fixation and reconstruction of bones, which is a structural and mechanical function rather than a therapeutic function that directly treats a disease or condition through biological, chemical, or energy-based means.
No
The device is described as an implant system for fixation of fractures and reconstruction of small bones, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the system is comprised of implant plates, bone screws, and instruments, all of which are physical hardware components made of titanium alloy and nitinol. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for fixing fractures and performing reconstructive procedures on bones in the hand, feet, wrist, ankles, fingers, and toes. This is a therapeutic and structural function within the body.
- Device Description: The device is comprised of implant plates, bone screws, and instruments made of titanium alloy and nitinol. These are materials used for surgical implants.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with bodily specimens for diagnostic purposes.
Therefore, the MotoBAND™ CP Implant System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MotoBANDTM 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. When used for these indications, the MotoBANDTM Implant System with the exception of the MTP plates and 2-hole plate may be used with the MotoCLIPTM Implant System.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The MotoBANDTM CP Implant System is comprised of implant plates, bone screws and instruments, having various features and sizes to accommodate differing patient anatomy. MotoBANDTM CP Implant System is compatible with MotoCLIPTM Implant System. The MotoBANDTM implants are manufactured from titanium alloy (ASTM F136). Each hole in the plate accepts locking or non-locking screws. Certain plates have a slot that accepts the MotoCLIPTM nitinol staple. MotoBANDTM CP Implant System is compatible with the MotoCLIPTM Implant System The MotoCLIPTM implants are made of biocompatible nitinol and are designed to exhibit superelastic properties.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre and post fatigue analyses were conducted on the plate and staple constructs to evaluate the wear and corrosion between the two devices. The test evaluated the cyclic polarization and the galvanic corrosion susceptibility of the MotoBANDTM CP plate and screws used with MotoCLIPTM nitinol compression staple. Test results indicate that the pre and post fatigue breakdown potentials are unchanged. The nitinol remains in a passive condition and exhibits a breakdown potential sufficiently above the galvanic mixed potential. Pit initiation due to galvanic interactions should not occur. Testing indicates that fatigue test of the MotoBANDTM titanium plates used with a MotoCLIPTM compression staple does not impart a failure mode to the staple that would indicate a risk for clinical use. A comparison of the breakdown potentials of the pre and post-fatigue samples indicates no significant difference in the samples. Test results indicate that the pre and post fatigue breakdown potentials are unchanged.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2016
CrossRoads Extremity Systems, LLC Mr. Vernon Hartdegen Senior Vice President of Operations 6055 Primacy Parkway, Suite 140 Memphis, Tennessee 38119
Re: K160300 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: February 4, 2016 Received: February 5, 2016
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 (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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Indications for Use
510(k) Number (if known) K160300
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™ CP Implant System with the execption of the MTP plates and 2-hole plate may be used with the MotoCLIP™ Implant System
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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date: | March 30, 2016 |
|---|---|
| Device Name: | MotoBANDTM 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: | MotoBANDTM 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: | K152306 MotoBANDTM CP Implant System |
| K083447 ANCHORAGETM CP | |
| Device Description: | The MotoBANDTM CP Implant System is comprised of |
| implant plates, bone screws and instruments, having various | |
| features and sizes to accommodate differing patient anatomy. | |
| MotoBANDTM CP Implant System is compatible with | |
| MotoCLIPTM Implant System. The MotoBANDTM implants are | |
| manufactured from titanium alloy (ASTM F136). Each hole | |
| in the plate accepts locking or non-locking screws. Certain | |
| plates have a slot that accepts the MotoCLIPTM nitinol staple. | |
| MotoBANDTM CP Implant System is compatible with the | |
| MotoCLIPTM Implant System The MotoCLIPTM implants are | |
| made of biocompatible nitinol and are designed to exhibit | |
| superelastic properties. | |
| Indications for Use: | The MotoBANDTM 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. When used for | |
| these indications, the MotoBANDTM Implant System with the | |
| exception of the MTP plates and 2-hole plate may be used | |
| with the MotoCLIPTM Implant System. | |
| Materials: | The MotoBANDTM CP Implant System implant components |
| are manufactured from titanium alloy (ASTM F136). | |
| The MotoCLIPTM Implant System implant components are | |
| manufactured from nickel titanium alloy (ASTM F2063) | |
| Substantial Equivalence: | The test results demonstrate that the use of the |
| MotoBANDTM CP plates and screw system with the use of | |
| the MotoCLIPTM nitinol compression staple (K142727) is | |
| substantially equivalent to the predicate devices | |
| (CrossRoads MotoBANDTM CP System - K152306 and the | |
| ANCHORAGETM CP System - K083447). Therefore, the | |
| fundamental scientific technology of the MotoBANDTM CP | |
| Implant System devices is the same as previously cleared | |
| devices. The MotoBANDTM CP Implant System is | |
| substantially equivalent for its intended use. | |
| Performance Testing: | Pre and post fatigue analyses were conducted on the plate |
| and staple constructs to evaluate the wear and corrosion | |
| between the two devices. The test evaluated the cyclic | |
| polarization and the galvanic corrosion susceptibility of the | |
| MotoBANDTM CP plate and screws used with MotoCLIPTM | |
| nitinol compression staple. Test results indicate that the pre | |
| and post fatigue breakdown potentials are unchanged. The | |
| nitinol remains in a passive condition and exhibits a | |
| breakdown potential sufficiently above the galvanic mixed | |
| potential. Pit initiation due to galvanic interactions should | |
| not occur. Testing indicates that fatigue test of the | |
| MotoBANDTM titanium plates used with a MotoCLIPTM | |
| compression staple does not impart a failure mode to the | |
| staple that would indicate a risk for clinical use. A | |
| comparison of the breakdown potentials of the pre and | |
| post-fatigue samples indicates no significant difference in | |
| the samples. Test results indicate that the pre and post | |
| fatigue breakdown potentials are unchanged. |
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