(75 days)
The EBI DFS® Joint Fixator is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external fixation modality. Possible applications include:
a) fracture dislocation with ligamentos instability;
b) comminuted intra-articular fracture; and
c) post traumatic reconstruction for joint stiffness.
The EBI DFS® Joint Fixator is a line extension of the currently marketed EBI XFIX DynaFix Fixation System. The EBI DFS O Joint Fixator is unilateral in design and is therefore available in both left and right configurations. The major components of the EBI DFS® Joint Fixator are as follows:
- DFS® Telescoping Arm .
- DFS® Dual Locking Connector Component .
- DFS® Inner Body Female Rotation Component .
- Central Elbow Disc .
- Precision Dual Locking Connector Component .
- Precision Inner Body Female Rotation Component .
- Precision Telescoping Stem .
The Central Elbow Disc is comprised of the following components:
- Elbow U-Connector .
- Elbow Rings (Outer and Inner) .
- Elbow Distractor .
- Optional Stopping Mechanisms .
The components of the EBI DFS® Joint Fixator are fabricated from the following materials, which conform to the requirements specified in the American Society of Testing and Materials (ASTM) standards:
- Stainless steel (ASTM Standards A582, A582M-95A and ASTM F899)
- Aluminum alloy Al 6061-6 ( ASTM B221)
- Delrin (ASTM D4181POMILL) .
The provided text describes a 510(k) summary for the EBI DFS® Joint Fixator, a medical device for external bone fixation. However, it does NOT contain information about acceptance criteria, device performance testing, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or details about training set ground truth.
The document primarily focuses on:
- Device Identification: Proprietary name, common name, classification, and predicate device.
- Device Description: Detailed explanation of components and materials of the EBI DFS® Joint Fixator.
- Intended Use: Specific medical conditions for which the device is intended.
- Substantial Equivalence: A comparison of the EBI DFS® Joint Fixator to a predicate device (Orthofix Elbow Fixator) to demonstrate their similarity in materials, function, and indication for use.
- FDA Clearance Letter: Official communication from the FDA confirming the device's substantial equivalence and permission to market.
Therefore, I cannot provide the requested information based on the provided text. The submission is focused on demonstrating substantial equivalence to an existing device, which often relies on comparative analysis rather than new, extensive performance studies with acceptance criteria in the same way a novel device might.
§ 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.