(315 days)
The Z™ - Series Modular Total Hip System Plasma Coated is indicated for use in total or partial hip replacements in patients suffering severe pain and disability due to structural hip problems such as rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated in patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and failed previous fusion, where bone stock is inadequate for other reconstruction techniques. CP Titanium Plasma Coated Implants are intended for Cement or Press Fit Applications.
Not Found
The provided document is a 510(k) clearance letter for a medical device (Z-Series Modular Total Hip System Plasma Coated) and does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot extract the requested information from this text.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.