DevicePMAs@therightstef:P070026_S003 JSONTXT 11 Projects

Approval for the addition of the trio-lock bps (bone preserving hip stem) and 28 mm ceramic femoral heads with a 12/14 taper and +1.5 mm, +5 mm, and 8.5 mm offset as compatible modular components to the system, and minor labeling changes to the device package insert and surgical technique. the device, as modified, will be marketed under the trade name depuy ceramax ceramic total hip system and is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of hips damaged as a result of noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post traumatic arthritis.