Search Results

The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stems for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: - Femoral neck and trochanteric fractures of the proximal femur; - . Osteonecrosis of the femoral head; - . Revisions procedures where other devices or treatments for these indications have failed

The iNSitu Bipolar Hip System consists of a factory assembled UHMWPE (ASTM F648) liner in a cobalt chrome (ASTM F75) outer shell, and UHMWPE (ASTM F648) retention ring with a Ti-6Al-4V ELI (ASTM F136) spring. These Bipolar Heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller Bipolar Heads (38 to 43 mm) have an inner diameter that mates with the subject 22mm diameter Femoral Head; the larger Bipolar Heads (44 to 60 mm) have an inner diameter that mates with the previously cleared 28 mm diameter Femoral Head. The iNSitu Bipolar Hip System may be used in conjunction with an iNSitu Total Hip System Femoral Stem (K161184/K172501) for hemiarthroplasty.

The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: · A severely painful and or disabled joint from osteoarthritis, theumator arthritis, avascular necrosis, or congenital hip dysplasia; · Acute traumatic fracture of the femoral head or neck; · Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

The subject device of this 510(k) notification is the Blade Femoral Stem, which is a line extension to the iNSitu Total Hip System. The Blade Femoral Stem is a collarless dual-tapered for biologic fixation. The neck is polished and narrowed in the anterior-posterior dimension to reduce the potential for impingement with the liner and to increase the range of motion (ROM), while maintaining flexural rigidity. The proximal portion of the stem possesses a porous structured commercially pure (CP) titanium coating for biologic fixation with bone. The hip stem has a smooth satin finish. There is a range of sizes that proportionally increase in diameter, stem length, and neck offset to accommodate a range of human hip anatomy. The range of stem sizes is offered in both standard and lateralized neck configurations. The Blade Femoral Stem is made from titanium alloy conforming to ASTM F136. The iNSitu Total Hip System includes a family of femoral stems (including the predicate iNSitu Femoral Stems and the subject Blade Femoral Stems), femoral head components, UHMWPE acetabular cups, acetabular hole covers, optional acetabular screws, instruments, and sterilization cases. With the extension Blade Femoral Stem, all other components of the subject device are identical to the predicate devices cleared in K161184 and K172501. The implants are packaged in single use, sterile packages with a 5-year shelf life and the re-usable instruments are contained in sterilization cases intended for steam sterilization.

The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: · A severely painful and or disabled joint from osteoarthritis, traumator arthritis, avascular necrosis, or congenital hip dysplasia; · Acute traumatic fracture of the femoral head or neck; · Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

The iNSitu Total Hip Replacement System is an artificial total hip replacement system includes femoral stems manufactured from forged Ti 6Al-4V ELI material, femoral heads manufactured from CoCr alloy and BIOLOX® delta ceramic, acetabular cups (additively manufactured from Ti), acetabular liners manufactured from Vitamin E polyethylene, acetabular bone screws, screw hole covers for the screw holes in the acetabular cups, and apical hole covers for the apical hole in the acetabular cups manufactured from Ti 6Al-4V ELI material.

The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: · A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia: · Acute traumatic fracture of the femoral head or neck; · Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

The iNSitu Total Hip Replacement System is an artificial hip replacement system. The system includes femoral stems, femoral heads, acetabular cups (additively manufactured), acetabular liners (Vitamin E polyethylene), acetabular bone screws, screw hole covers for the scetabular cups, and apical hole covers for the apical hole in the acetabular cups.