(50 days)
The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
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I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, ground truth establishment methods, expert qualifications, or adjudication methods for a medical device.
The document is a 510(k) clearance letter from the FDA for a device called "HyProCure Subtalar Implant System." It states that the device is "substantially equivalent" to legally marketed predicate devices. It lists the indications for use, but does not include any performance data, study details, or acceptance criteria.
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§ 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.