Search Results

The Smith & Nephew Locking Bone Plate System is used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones (particularly in osteopenic bone); treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.

Components in the Smith & Nephew Locking Bone Plate System are for single use only.

The Smith & Nephew Locking Bone Plate System is a modification of the Smith & Nephew Bone Plate System cleared under K993106. Like the predicate devices listed below, components include various sizes of contoured and straight, locking bone plates, locking bone screws, and compression screws made from stainless steel. Implantable locking plates/screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text does not contain information about acceptance criteria, device performance, or any studies with specific details like sample sizes, ground truth establishment, or expert involvement. The document is a 510(k) summary for the Smith & Nephew Locking Bone Plate System, primarily focused on establishing substantial equivalence to previously cleared predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the specified information.

Ask a specific question about this device