(76 days)
The Howmedica® SCN Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.
The Howmedica® SCN Nail consists of supracondylar nails in various diameters and lengths, cross-locking screws, condyle screws, a condyle nut and a set screw. The nails are inserted using an opened or closed retrograde technique for the intramedullary nailing of distal femoral fractures. All of the components are fabricated from medical grade stainless steel.
This document is related to a 510(k) premarket notification for a medical device (Howmedica® SCN Nail), which details its intended use and claims substantial equivalence to existing devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These are typically part of a separate study report or detailed submission to the FDA, not usually summarized in the 510(k) summary or the FDA clearance letter itself.
Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance data against acceptance criteria.
§ 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.