(51 days)
The Biopro subtalar 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. Conditions include:
Flat foot treatment in children and adolescents
Congenital flat foot
Unsuccessful long term orthopedic treatment (orthodics)
Tarsal coalitions
Painfully flat foot
Supple deformity in posterior tibial tendon dysfunction
Paralytic flat foot
Subtalar instability
The Biopro Sub-talar Implant is a combination of three components. Two components made of titanium allow and one component made of UHMW Polyethylene. It will be provided in a range of diameters, including 8mm-12mm in diameter. The device will be cannulated for precise implantation. The device is implanted using a standard 0.125" square driver which is cannulated.
This document is a 510(k) summary for the Biopro Sub-talar Implant, which is a bone fixation fastener. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it describes the device, its intended use, and indicates that it is substantially equivalent to predicate devices. The FDA letter confirms the substantial equivalence determination.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document does not contain this type of information.
§ 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.