(608 days)
The LactoSorb® Panels and Fasteners are used in maintaining the position of bony of bony fragments or morselized bone graft in Iliac Crest autograft procedures. This product is not intended for use in the spine or joint space. This product is also not indicated for pelvic fracture fixation.
The LactoSorb® devices are made of bioresorbable and Ine backed activers that have been used in surgical procedures Brocompacible porymers chac have copolymer is synthetic polyester derived from lactic and glycolic acids. polylactic/polyglycolic acid copolymer degrades and resorbs IN vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found meconocible by the both soft tissue and bone tissue. Both co be brocomputible in lostudies have proven the safety and preciliadar and these devices in trauma and reconstructive procedures in the midface and craniofacial skeleton.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Biomet LactoSorb® Panels and Fasteners, focusing on their substantial equivalence to predicate devices and their intended use. It does not contain details about specific performance metrics, studies with sample sizes, expert involvement, or ground truth establishment.
§ 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.