(74 days)
The ULTIMA Fx Femoral Hip Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, traumatic and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The ULTIMA Fx Femoral Hip Stems will be offered in both a cemented design and uncemented design, both manufactured of cobalt-chromium-molybdenum alloy (Co-Cr-Mo). The stems will be offered with the following features:
| Feature | ULTIMA FX Cemented Stem | ULTIMA FX Press-Fit Stem |
|---|---|---|
| Distal Diameter | 8 - 11 mm | 10.5 - 15 mm |
| Length | 130 - 165 mm | 125 - 165 mm |
| Cement Mantle | 2.0 - 3.6 mm | N/A |
| Offset | 37 - 46 mm | 34 - 46 mm |
| Cobra Flange | Yes | No |
The ULTIMA Fx Femoral Hip Stems can be used in either the right or left hip, and are designed to mate with the following hip heads.
This is a 510(k) premarket notification for a medical device cleared in 1996. The provided text is a summary of the device description, intended use, and comparison to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.
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§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.