(70 days)
No
The summary describes a mechanical implant system and its performance testing, with no mention of AI or ML.
No
The device is described as an implant system for fixation of fractures and reconstruction of small bones, which are structural and reparative functions, not therapeutic.
No
The device is an implant system used for fixation and reconstruction of bones, not for diagnosing medical conditions. Its intended use describes surgical procedures, not diagnostic ones.
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 describes a surgical implant system used for the fixation and reconstruction of bones in the hand, feet, wrist, ankles, fingers, and toes. This is a therapeutic and structural function within the body.
- Device Description: The description details implant plates and instruments, which are physical devices used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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 MTP plates and 2-hole plate may be used with the MotoCLIPTM Implant System.
Product codes
HWC, HRS
Device Description
The MotoBAND™ CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries include valgus options of 0°, 5° and 10°, dorsiflexion options of 0°, 2.5°, 5°, 7.5° and 10° and options to use either a 15mm or 18mm nitinol clip. MotoBAND™ CP Implant System is compatible with MotoCLIP™ Staple.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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 (CrossRoads MotoBAND™ CP System K152306 and K160300). The results demonstrate the predicted performance of the MotoBAND™ CP Implant System is substantially equivalent to the predicate device.
Theoretical analysis of the worst case MotoBAND™ CP Implant System shows that the strength of the subject plates exceeds the strength of the worst-case plate in the predicate system (K152306 and K160300). The results demonstrate the predicted performance of the MotoBAND™ CP Implant System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160300 MotoBAND™ CP Implant System, K152306 MotoBAND™ CP Implant System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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/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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2018
CrossRoads Extremity Systems, LLC % Christine Scifert Executive Vice President MRC-X, LLC 6075 Poplar Avenue Memphis. Tennessee 38119
Re: K173710
Trade/Device Name: MotoBANDTM CP Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: January 17, 2018 Received: January 18, 2018
Dear Ms. Scifert:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Katherine D. Kavlock -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)
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 MTP plates and 2-hole plate may be used with the MotoCLIPTM 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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510(k) Summary
| Date: | February 8, 2018 |
|---|---|
| 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: | Christine Scifert, MS, MEM |
| Executive Vice President | |
| MRC-X, LLC | |
| 901-831-8053 | |
| christine.scifert@mrc-x.com | |
| Company Contact: | Chad Hollis |
| Vice President of Research & Development | |
| CrossRoads Extremity Systems | |
| 901.221.8406 | |
| chollis@crextremity.com | |
| Trade Name: | MotoBAND™ CP Implant System |
| Common Name: | Plate System |
| Classification: | Class II |
| Regulation Number: | 888.3040, Smooth or threaded metallic bone fixation |
| fastener | |
| 888.3030, Single/multiple component metallic bone | |
| fixation appliances and accessories | |
| Panel: | Orthopedic |
| Product Code: | HWC, HRS |
| Predicate Devices: | Primary Predicate: |
| K160300 MotoBAND™ CP Implant System | |
| Additional Predicate: | |
| K152306 MotoBAND™ CP Implant System | |
| Device Description: | The MotoBAND™ CP Implant System is comprised of |
| implant plates and instruments, having various features and | |
| sizes to accommodate differing patient anatomy. Plate | |
| geometries include valgus options of 0°, 5° and 10°, | |
| dorsiflexion options of 0°, 2.5°, 5°, 7.5° and 10° and options | |
| to use either a 15mm or 18mm nitinol clip. MotoBAND™ | |
| CP Implant System is compatible with MotoCLIP™ Staple. | |
| 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. When used | |
| for these indications, the MotoBAND™ CP Implant | |
| System with the exception of the MPJ plates and 2-hole | |
| plate may be used with the MotoCLIP™ Implant System. | |
| 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 (CrossRoads MotoBAND™ | |
| CP System K152306 and K160300). The results | |
| demonstrate the predicted performance of the | |
| MotoBAND™ CP Implant System is substantially |
|
| Performance Testing: | Theoretical analysis of the worst case MotoBAND™ CP
Implant System shows that the strength of the subject plates
exceeds the strength of the worst-case plate in the predicate
system (K152306 and K160300). The results demonstrate |
4
5
the predicted performance of the MotoBAND™ CP Implant System is substantially equivalent to the predicate device.
- The fundamental scientific technology of the MotoBAND™ Conclusion: CP Implant System devices is the same as previously cleared devices. Therefore, the MotoBAND™ CP Implant System is substantially equivalent for its intended use.