(30 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals Andergoing primary surgery for hip replacement due to osteoarthritis, theumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also the surgeon as the preferrod a oning spondylitis, congenital hip dysplasia, revision of potentially marcated reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
The Exactech centralizers are designed to provide central placement of Exactech cemented stems within the femoral canal. The components have three fins and a tapered post for attachment to Exactech cemented femoral components. The device is composed of polymethylmethacrylate (PMMA) and comes in sizes ranging from 7mm to 17mm in diameter.
The provided text does not contain a study that proves the device meets specific acceptance criteria. This document is a 510(k) Summary of Safety and Effectiveness for the Exactech® Femoral Stem Centralizers, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a specific study against predefined acceptance criteria.
Therefore, I cannot populate the table or answer the questions related to a study proving acceptance criteria. The document states:
"The proposed Exactech Centralizers are similar in design and material specifications to other products legally marketed in the United States, most notably Exactech's predicate centralizer design cleared through premarket notification #K862234."
This indicates that the primary method for demonstrating safety and effectiveness is through substantial equivalence, not through a new performance study with specific acceptance criteria as defined in the prompt.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.