(34 days)
The KALIX II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
- flat foot treatment in children and adolescents -
- congenital flat foot -
- non successful long term orthopaedic treatment (shoes, insoles ... ) -
- tarsal coalitions -
- painfully flat foot -
- supple deformity in posterior tibial tendon dysfunction -
- paralytic flat foot -
- subtalar instability. -
The KALIX® II Flat Foot implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. This is the same indication for use as the Kalix Implant, K001231.
This document is a 510(k) summary for the KALIX® II Flat Foot implant, which is a metallic bone fixation fastener. It does not describe an AI/ML device, nor does it contain information about acceptance criteria, device performance metrics, or study designs typically associated with such devices.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document primarily focuses on establishing substantial equivalence to a predicate device (KALIX® implant, K001231) based on similar intended use, materials, basic design, instructions for use, and manufacturing processes.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.