(28 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™ Implant System with the exception of the 2-hole plate may be used with the MotoCLIP™ HiMAX™ Implant System.
The subject MotoBAND CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries are 5° valgus and have options of 0°,5°, and 10° dorsiflexion and can be used with 18mm, 20mm or 25mm nitinol clip. Non-locking and poly-axial locking screws are included in the system: 3.0mm diameter and 3.5mm diameters in lengths of 10-50 mm. MotoBAND CP Implant System is compatible with MotoCLIP/HiMAX Clips.
The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) premarket notification letter from the FDA to CrossRoads Extremity Systems, LLC regarding the MotoBAND CP Implant System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against defined acceptance criteria through a specific study.
The key points from the document regarding the device are:
- Device Name: MotoBAND™ CP Implant System
- Intended Use: Stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
- Comparison to Predicate: The submission compares the MotoBAND CP Implant System to a primary predicate (K173710 MotoBAND CP Implant System) and an additional predicate (K181410 MotoCLIP™/HiMAX™ Implant System).
- Changes from Predicate: The subject device includes:
- Longer bridge length clips (20mm and 25mm)
- Longer length screws (32-50mm)
- Plate geometry modification for clip compatibility (maximum plate length decreased, thickness and width similar).
- Performance Testing (Engineering Analysis): An engineering analysis of the "worst case" MotoBAND™ CP Implant System with MotoCLIP™/HIMAX™ Implant System was performed.
- Results: This analysis showed that the strength of the plates, staple bending strength and bending stiffness, and staple/screw fixation performance exceeds the strength of the worst-case implants in the predicate system.
- Conclusion from Analysis: "No additional mechanical testing is required. The results demonstrate the performance of the subject MotoBAND CP Implant System is substantially equivalent to the predicate device."
Therefore, based on the provided text, the specific information requested in the prompt (acceptance criteria, details of a study proving compliance, sample sizes, ground truth establishment, MRMC studies, etc.) is not present. The FDA clearance is based on a demonstration of substantial equivalence through engineering analysis comparing the new device to a predicate, not on a clinical or performance study with defined acceptance criteria for standalone performance.
§ 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.