(253 days)
The Synthes OrthoMesh Resorbable Graft Containment system is indicated for use in maintaining the relative position of weak bony tissue such as bone grafts, bone graft substitutes or bone fragments from comminuted fractures.
OrthoMesh implants may be used alone (without traditional rigid fixation) to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in non-load-bearing reconstructive procedures involving areas where bone stability has not been compromised, such as tumor resections and iliac crest graft harvest sites.
OrthoMesh implants must be used in conjunction with traditional rigid fixation in load bearing applications to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in reconstructive procedures involving long bones, flat bones, short bones, irregular bones, appendicular skeleton and thorax. These devices are not intended for use in the spine. The devices are not intended for load bearing indications unless used in conjunction with traditional rigid fixation
The Synthes OrthoMesh Resorbable Graft Containment System is comprised of meshes of 0.5mm, 0.8mm and 1.2mm thickness, and lengths and widths ranging from 48mm to 125mm. The Synthes OrthoMesh Resorbable Graft Containment System is also comprised of screws with a diameter ranging from 1.5mm to 2.5mm, and a length ranging from 4mm to 8mm. These implants are made from the resorbable copolymer poly (L-lactide-co-glycolide) that resorbs in vivo by hydrolysis into lactic and glycolic acids, and that are then metabolized by the body. Synthes OrthoMesh implants are resorbed completely within approximately 12 months. The implants are provided sterile and are intended for single patient use. OrthoMesh may be held in place with screws.
The provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria.
The document is a 510(k) summary and an FDA clearance letter for the Synthes OrthoMesh Resorbable Graft Containment System. It describes the device, its intended use, contraindications, and declares its substantial equivalence to predicate devices. However, it does not include performance data, clinical study results, or specific acceptance criteria for device performance.
Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, data provenance, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.
§ 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.