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The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal femur in total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include: - Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis; and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - Patients with failed previous surgery where pain, deformity, or dysfunction persists. - Revision of previously failed hip arthroplasty.

Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured from forged titanium alloy and are available in three lengths (165mm, 185mm, and 205mm). The neck design of both stems is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper. The Wagner SL Revision Stem Lateral incorporates a circular stem cross-section and equally spaced conical anchorage ribs, which run nearly the full length of the stem, as do the ribs on the previously cleared Wagner SL Revision Stem. The surface of both stems is rough-blasted. To achieve the lateralization of the modified device, the CCD (i.e., neck) angle was lengthened. To compensate for the increased bending moments and lateral stresses, which result from the increased offset, the rib structure was modified so that the greatest bending moment would not be at the base of the rib; and the ribs were widened, which led to an increase in the stem strength. In addition, a threaded coupling was added to the proximal portion of the stem for use with the new impacter/extractor. The stem neck was shortened to increase the range of motion, and two small holes were added to the proximal portion of the stem for securing non-metallic suture material.

The CLS™ Spotorno™ Femoral Stem is intended for cementless use in total hip replacement in treatment of the following: - patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.g. rheumatoid arthritis; - those patients with failed previous surgery where pain, deformity, or dysfunction persists; - revision of previously failed hip arthroplasty.

The CLS™ Spotorno™ Femoral Stem is intended for use as a prosthetic replacement of the proximal portion of the femur during total hip arthroplasty. This Special 510(k) incorporates the following changes as compared to the original device configuration: 1) addition of the CLS 125° stem, with an increased offset; and 2) incorporation of a slim neck and short taper. Below the resection line, the design of the modified stem remains the same as the legally marketed device.