(170 days)
Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods. Dolphix® External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with soft tissue injuries; -
- Temporary stabilization of fractures in the context of polytrauma: -
- Temporary stabilization of certain pelvic fractures or pelvic ring injuries; ...
- Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure;
- Temporary stabilization of non-unions; -
- Intra-operative temporary stabilization tool to assist with indirect reduction. -
Dolphix® External Fixation System is intended for use in a non-weight bearing patient.
Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods.
The provided text is a 510(k) premarket notification letter from the FDA to CITIEFFE s.r.l for their Dolphix® External Fixation System. This document is a regulatory communication concerning the substantial equivalence of a medical device and does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, not on specific performance data or clinical study results.
§ 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.