(59 days)
The ULTiMAX™ brand Distal Femoral Intramedullary Rod System is indicated for single use to stabilize distal femoral fractures, including supracondylar fractures, severely comminuted supracondylar fractures with difficult intra-articular extension, fractures that require stabilization of the femoral condylar segment, distal fractures in osteoporotic bone, pathologic fractures, pseudoarthrosis, malunions and failed distal femoral osteosynthesis.
ULTiMAX™ Distal Femoral Intramedullary Rod System
I am sorry, but based on the provided document, I cannot extract information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the ULTiMAX™ Distal Femoral Intramedullary Rod System, which primarily discusses the substantial equivalence of the device to a predicate device and its indications for use. It does not contain details about specific performance acceptance criteria or performance study results.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.