(87 days)
The Friedl Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:
- pertrochanteric femoral fractures -
- subtrochanteric femoral fractures and -
- lateral femoral neck fractures. -
Internal fixation with the long Fried! Gliding Nail is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the Friedl Gliding Nail system is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weightbearing stability after varus and valgus revision osteotomies of the proximal femur.
The FRIEDL Gliding Nail System is an all-purpose locking nail system for primary load stability in pertrochanteric femoral fractures, subtrochanteric femoral fractures, and lateral femoral neck fractures. This system consists of several sizes of intramedullary nails, femoral neck blades, and distal locking pins. The Fried Gliding Nail System is made of Wrought High Nitrogen Stainless Steel according to ISO 5832-9.
The provided text is a 510(k) summary for the FRIEDL Gliding Nail System, a medical device for orthopedic fixation. It discusses the device's description, indications for use, and its substantial equivalence to a predicate device.
However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. It is a regulatory submission demonstrating substantial equivalence to a previously cleared device, not a report of a clinical or performance study with defined acceptance criteria.
Therefore, I cannot provide the requested table and study details from the given input.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.