(78 days)
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
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.
MotoBAND™ CP Implant System
This document describes the acceptance criteria and study proving the MotoBAND™ CP Implant System meets these criteria. The device is intended 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.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the biocompatibility and mechanical integrity of the device, particularly when the MotoBAND™ CP system is used in conjunction with the MotoCLIP™ nitinol compression staple. The acceptance criteria are implicitly tied to the absence of adverse galvanic corrosion and a maintained passive state of the nitinol component, along with mechanical stability under fatigue.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Galvanic Corrosion | Nitinol component should remain in a passive condition and exhibit a breakdown potential sufficiently above the galvanic mixed potential, indicating no pit initiation due to galvanic interactions. Breakdown potentials pre- and post-fatigue should remain 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." "Test results indicate that the pre and post fatigue breakdown potentials are unchanged." "A comparison of the breakdown potentials of the pre and post-fatigue samples indicates no significant difference in the samples." |
| Mechanical Fatigue | The combined construct (plate and staple) should function without failure that would indicate a risk for clinical use, particularly demonstrating that the fatigue test of the MotoBAND™ titanium plates does not impart a failure mode to the MotoCLIP™ compression staple. Breakdown potentials pre- and post-fatigue should remain unchanged. | "Testing indicates that fatigue test of the MotoBAND™ titanium plates used with a MotoCLIP™ compression staple does not impart a failure mode to the staple that would indicate a risk for clinical use." "Test results indicate that the pre and post fatigue breakdown potentials are unchanged." |
| Wear and Corrosion | Minimal wear and corrosion between the plate and staple constructs under cyclic loading. | "Pre and post fatigue analyses were conducted on the plate and staple constructs to evaluate the wear and corrosion between the two devices." (The successful outcome reported in the other categories implies acceptable wear and corrosion performance.) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set. The data provenance is described as performance testing conducted by the manufacturer, CrossRoads Extremity Systems, as part of their 510(k) submission. This is retrospective testing performed on manufactured devices. The country of origin of the data is implicitly the USA, given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study involves mechanical and electrochemical performance testing of a medical device's physical properties, not a diagnostic or AI-driven system requiring expert assessment of ground truth in medical images or conditions. The "ground truth" here is objective scientific measurement (e.g., breakdown potential, mechanical failure).
4. Adjudication method for the test set
Not applicable. As described in point 3, this is objective performance testing, not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a performance study for a surgical implant system, not a diagnostic device or an AI assistant for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical implant, not an algorithm or AI system.
7. The type of ground truth used
The ground truth used for this performance testing is established through objective scientific measurements and analyses in a laboratory setting. This includes:
- Electrochemical measurements for cyclic polarization and galvanic corrosion susceptibility.
- Mechanical testing for fatigue and structural integrity.
- Material science principles (e.g., passive condition of nitinol, breakdown potential).
8. The sample size for the training set
Not applicable. This is a performance study for a physical device, not a machine learning model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As described in point 8, there is no training set for this type of performance study.
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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
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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 OrthoDiscoveryGroup LLC)6055 Primacy Parkway, Suite 140Memphis, TN 38119 USAPhone: 901.221.8406 |
| Primary Contact: | Vernon Hartdegen, Sr. VP of Operations901.221.8406Vhartdegen@crextremity.com |
| Trade Name: | MotoBANDTM CP Implant System |
| Common Name: | Plate System |
| Classification: | Class II |
| Regulation Number: | 888.3030 Single/multiple component metallic bone fixationappliances and accessories888.3040, Smooth or threaded metallic bone fixation fastener |
| Panel: | Orthopedic |
| Product Code: | HRS, HWC |
| Predicate Devices: | K152306 MotoBANDTM CP Implant SystemK083447 ANCHORAGETM CP |
| Device Description: | The MotoBANDTM CP Implant System is comprised ofimplant plates, bone screws and instruments, having variousfeatures and sizes to accommodate differing patient anatomy.MotoBANDTM CP Implant System is compatible withMotoCLIPTM Implant System. The MotoBANDTM implants aremanufactured from titanium alloy (ASTM F136). Each holein the plate accepts locking or non-locking screws. Certainplates have a slot that accepts the MotoCLIPTM nitinol staple.MotoBANDTM CP Implant System is compatible with theMotoCLIPTM Implant System The MotoCLIPTM implants aremade of biocompatible nitinol and are designed to exhibitsuperelastic properties. |
| Indications for Use: | The MotoBANDTM CP Implant System is indicated forstabilization and fixation of fresh fractures, revisionprocedures, joint fusion and reconstruction of small bones ofthe hand, feet, wrist, ankles, fingers and toes. When used forthese indications, the MotoBANDTM Implant System with theexception of the MTP plates and 2-hole plate may be usedwith the MotoCLIPTM Implant System. |
| Materials: | The MotoBANDTM CP Implant System implant componentsare manufactured from titanium alloy (ASTM F136).The MotoCLIPTM Implant System implant components aremanufactured from nickel titanium alloy (ASTM F2063) |
| Substantial Equivalence: | The test results demonstrate that the use of theMotoBANDTM CP plates and screw system with the use ofthe MotoCLIPTM nitinol compression staple (K142727) issubstantially equivalent to the predicate devices(CrossRoads MotoBANDTM CP System - K152306 and theANCHORAGETM CP System - K083447). Therefore, thefundamental scientific technology of the MotoBANDTM CPImplant System devices is the same as previously cleareddevices. The MotoBANDTM CP Implant System issubstantially equivalent for its intended use. |
| Performance Testing: | Pre and post fatigue analyses were conducted on the plateand staple constructs to evaluate the wear and corrosionbetween the two devices. The test evaluated the cyclicpolarization and the galvanic corrosion susceptibility of theMotoBANDTM CP plate and screws used with MotoCLIPTMnitinol compression staple. Test results indicate that the preand post fatigue breakdown potentials are unchanged. Thenitinol remains in a passive condition and exhibits abreakdown potential sufficiently above the galvanic mixedpotential. Pit initiation due to galvanic interactions shouldnot occur. Testing indicates that fatigue test of theMotoBANDTM titanium plates used with a MotoCLIPTMcompression staple does not impart a failure mode to thestaple that would indicate a risk for clinical use. Acomparison of the breakdown potentials of the pre andpost-fatigue samples indicates no significant difference inthe samples. Test results indicate that the pre and postfatigue breakdown potentials are unchanged. |
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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.