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The NextStep Arthropedix Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The NextStep Arthropedix Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NextStep Arthropedix Total Knee System is designed for cemented use only.

The subject device submission includes a combination of devices based on previously cleared devices (K142649 and K150783) and devices with new designs. This submission will include several identical devices reviewed in K142649 and K150783, new devices not yet reviewed by FDA, and new cleaning, packaging, and sterilization validations for all implants. The subject device submission includes 2 system options for total knee replacement: - Option 1 – Posterior Stabilized (PS), Cruciate Retaining (CR), and Ultra Congruent Cruciate Retaining (UC-CR) patellofemorotibial total knee replacement system that is based on the Progressive Orthopedic Total Knee System cleared in K142694 and K150783 - Includes additional femoral component sizes, additional vitamin E UHMWPE material option for the symmetrical tibial inserts, and manufacturing patellar components from vitamin E UHMWPE only. - Option 2 – Medial Pivot Total Knee System, including cruciate retaining (MP-CR) and cruciate substituting (MP-CS) tibiofemoral articulation

TheRay Collared and Collarless 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. TheRay Collared and Collarless Total Hip System femoral stems are intended for cementless fixation. The acetabular cup is intended for cementless fixation. The porous structured surfaces on the acetabular cup provide biological fixation in a cementless application. The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stem or TheRay Collared or Collarless Femoral Stem 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; · Revision procedures where other devices or treatments for these indications have failed.

TheRay Collared and Collarless Hip System includes the new subject femoral stems, along with previously cleared femoral heads (K161184, K220336), acetabular cups (additively manufactured – K161184 and K191936), acetabular liners (vitamin E polyethylene – K161184), acetabular bone screws (K161184), screw hole covers for the screw holes in the acetabular cups (K161184), and apical hole covers for the acetabular cups (K161184). The subject femoral stem implant features a forged triplaner Ti-6Al-4V ELI substrate and an applied dual coating comprised of plasma-sprayed commercially pure titanium (CPTi) and hydroxyapatite (HA). The collared version of the subject TheRay Femoral Stem features a collar on the medial aspect of the stem above the coating that is designed to seat on the native resected calcar. The collarless version of the subject TheRay Femoral Stem is identical to the collared version, less the medial collar. The iNSitu Bipolar Hip System has been previously cleared for use in K191297 and 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 a 22mm diameter Femoral Head; the larger Bipolar Heads (44 to 60 mm) have an inner diameter that mates with a 28 mm diameter Femoral Head. The iNSitu Bipolar Hip System may be used in conjunction with the subject TheRay Collared and Collarless Hip System Femoral Stems.