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Approval for the addition of an intermediate ceramic liner size (36/48g); three replacement 36mm od ceramic heads with consistent offset (-3.5 mm, 0 mm, and +3.5 mm); and femoral stems and acetabular shells as specified in submissions received march 8, 2006 and june 21, 2006 which have been round substantially equivalent via the 510(k) process. The device, as modified, will be marketed under the trade name ceramic lineage/ transcend articulation system and is indicated for use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
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