(182 days)
The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.
The Latarjet Cortical Screw Set consists of an implantable fixation screw which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall lengths: 36mm - 42mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied non-sterile, for single patient use.
This 510(k) summary for the Latarjet Cortical Screw Set indicates that it is a bone fixation screw and therefore does not involve an AI/ML powered device. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance verified by validation (likely mechanical or material testing, not clinical studies in the context of AI/ML).
Therefore, the requested information regarding acceptance criteria, study details, ground truth, expert involvement, and AI-related metrics (such as MRMC studies, standalone performance, training sets) is not applicable to this device.
The document primarily addresses the substantial equivalence of a physical medical device (bone screw) to existing devices, relying on comparisons of design, materials, and intended function rather than algorithmic performance evaluation.
§ 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.