(45 days)
Synthes (USA) 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.
The Synthes (USA) 6.5 mm Cancellous Screws incorporate a fully threaded shaft, 4.0 mm core diameter, and have a flat head profile with rounded edges. They are available in lengths ranging from 60 mm to 130 mm in both Stainless Steel and Titanium Alloy. The screws are provided STERILE and NON STERILE.
The provided text is a 510(k) summary for the Synthes (USA) 6.5 mm Cancellous Screws. It describes the device, its intended use, and its classification and predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies, sample sizes for testing or training, expert ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).
The document is a regulatory submission demonstrating substantial equivalence to previously marketed devices, not a scientific study reporting performance metrics against acceptance criteria. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 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.