(28 days)
Not Found
No
The description focuses on the mechanical properties and function of a nitinol staple for bone fixation, with no mention of AI or ML.
Yes
The device is indicated for bone fragment osteotomy fixation and joint arthrodesis, which are therapeutic interventions. Its function is to provide bone fixation in managing fractures and reconstruction surgery, directly contributing to healing and restoring function.
No
Explanation: The device is a staple implant system used for bone fixation in fracture management and reconstruction surgery, not for diagnosing medical conditions.
No
The device description explicitly states that the system includes "implants and the related instruments needed for implantation," which are physical hardware components made of nitinol.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hand and foot bone fragment osteotomy fixation and joint arthrodesis." This describes a surgical procedure performed directly on the patient's body to fix bones.
- Device Description: The description details a surgical implant made of nitinol that is inserted into bone to provide fixation and compression.
- 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, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to be implanted within the body for structural support.
N/A
Intended Use / Indications for Use
The MotoCLIP™/HiMAX™ Step Staple Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The MotoCLIP™/HiMAX™ Step Staple Implant System gives the surgeon a means of bone fixation in the management of bone fractures and reconstruction surgery. The MotoCLIP™/HiMAX™ Step Staple Implant System includes implants and the related instruments needed for implantation. The implants are made of nitinol. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Finite element analysis was performed utilizing the worst-case sizes the subject MotoCLIP™/HiMAX™ Step Staple Implant System. This analysis showed the subject device to be substantially equivalent in terms of bending strength, bending stiffness, and pullout strength to the predicate CrossRoads CrossCLIP™ Staple (K142727).
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.
Not Found
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.
0
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CrossRoads Extremity Systems, LLC % Theresa Leister Senior Consultant MRC-X. LLC 6075 Poplar Ave Memphis. Tennessee 38119
August 9, 2018
Re: K181866
Trade/Device Name: MotoCLIP/HiMAX Step Staple 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: JDR Dated: July 11, 2018 Received: July 12, 2018
Dear Theresa Leister:
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.
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 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,
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) K181866
Device Name
MotoCLIP™/HiMAX™ Step Staple Implant System
Indications for Use (Describe)
The MotoCLIP™/HiMAX™ Step Staple Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
| 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
MotoCLIP™/HiMAX™ Step Staple Implant System July 29, 2018
| Company: | CrossRoads Extremity Systems, LLC
6055 Primacy Parkway, Suite 140
Memphis, TN 38119 |
|--------------------------------|-------------------------------------------------------------------------------------------|
| Establishment
Registration: | 3011421599 |
| Primary Contact: | Theresa Leister
Phone: 901-489-1715 |
| Company Contact: | Chad Hollis
Phone: 901-221-8406 |
| Trade Name: | MotoCLIP™/HiMAX™ Step Staple Implant System |
| Common Name: | Staple, Fixation, Bone |
| Classification: | Class II |
Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
| Panel: | 87- Orthopedic |
|---|---|
| Product Code: | JDR |
| Predicate Devices: | CrossRoads CrossCLIPTM Staple (K142727) |
| CrossRoads MotoCLIPTM/HiMAX Implant System (K181410) | |
| Biomedical Enterprises, Speed Shift (K124022) |
Device Description:
The MotoCLIP™/HiMAX™ Step Staple Implant System gives the surgeon a means of bone fixation in the management of bone fractures and reconstruction surgery. The MotoCLIP™/HiMAX™ Step Staple Implant System includes implants and the related instruments needed for implantation. The implants are made of nitinol. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.
4
Indications for Use:
The MotoCLIP™/HiMAX™ Step Staple Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
Substantial Equivalence:
The subject MotoCLIP™HiMAX™ Step Staple Implant System components are substantially equivalent to the following predicate devices:
Primary Predicate: CrossRoads CrossCLIP™ Staple (K142727) Additional Predicate: CrossRoads MotoCLIP™/HiMAX Implant System (K181410) Biomedical Enterprises, Speed Shift (K124022)
The subject components are similar to the predicate devices in terms of indications, geometry, and materials. Mechanical analysis has shown the subject devices to be substantially equivalent in mechanical strength to the previously cleared CrossCLIP™ Staple (K142727). Thus, it can be concluded that the subject devices raise no new questions of safety and effectiveness and are substantially equivalent to the predicate devices.
Performance Testing:
Finite element analysis was performed utilizing the worst-case sizes the subject MotoCLIP™/HiMAX™ Step Staple Implant System. This analysis showed the subject device to be substantially equivalent in terms of bending strength, bending stiffness, and pullout strength to the predicate CrossRoads CrossCLIP™ Staple (K142727).
Conclusion:
There are no substantial differences between the MotoCLIP™/HiMAX™ Step Staple Implant System and the predicate devices with respect to intended use and technological characteristics, including basic design, materials of manufacture, mechanical properties, and intended effect.
Therefore, the MotoCLIP™/HiMAX™ Step Staple Implant System can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.