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The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, undergoing surgery for total knee replacement due to: - · Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis. - . Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result. - . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. . The Neo Total Knee System components are indicated for use only with cement and are single use devices.

The NEO Total Knee System was cleared for marketing in April 2012, under 510(k) #K120313. The predicate knee system includes a cruciate retaining (CR) femoral component design, tibial trays, CR tibial inserts for use with intact posterior cruciate ligament(PCL), and patellar components. The subject 510(k) adds ultra congruent (UC) tibial inserts for use when the PCL is sacrificed. There are no changes to materials or to system component size offering. The Neo Knee System CR femoral components, when used with the mating Neo Knee System CR and UC articular surfaces, are designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

PIPELINE 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, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia: - Acute traumatic fracture of the femoral head or neck; - Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement. The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application. The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

The predicate Pipeline Total Hip System (K112802) and PBP Total Hip System (K122802) are artificial hip replacement systems that include femoral stems (titanium alloy and CP titanium), femoral heads (cobalt chromium or alumina ceramic), acetabular shells (titanium alloy, porous structured technology (PST™)), acetabular liners (ultrahigh molecular weight polyethylene, standard and highly crosslinked Vitamin E), acetabular bone screws (titanium alloy) and dome hole covers (titanium alloy) for the holes in the acetabular shells. This subject 510k adds the following components to the existing hip systems: - A smaller, size 1 femoral stem; . - The option of hip stems (all sizes) with 3 tantalum beads, to allow the surgeon to . perform radiostereometric analysis(RSA) to measure implant migration; and - . The option of acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells.

The Pipeline 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, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia. - Acute traumatic fracture of the femoral head or neck. - Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement. The Tapered Hip Stem and PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured (PST™) surface provides biological fixation when used in a cementless application. The Pipeline Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

This 510(k) addresses the addition of the following components (already cleared under 510(k) #K122158) to the Pipeline Total Hip System: - . HA-coated Acetabular Shells feature a thin HA coating applied over the porous structured (PST) shells in a range of sizes, - . Biolox® delta Ceramic Femoral Heads available in a range of diameters and extension options, - . 40mm CoCr Femoral Heads, and - . 40mm inner diameter Highly Crosslinked Vitamin E UHMWPE Acetabular Liners. These components are compatible with the total hip system determined substantially equivalent as the Pipeline Total Hip System in 510(k) #K112802 and as the PBP Total Hip System in 510(k) #K122158.

The Pipeline Knee System is indicated for skeletally mature patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, - . Collagen disorders, and/or avascular necrosis of the femoral condyle, - . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, - . Moderate valgus, varus, or flexion deformities, - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot otherwise be obtained at the time of surgery.. Pipeline Knee System components are indicated for use only with cement, and are single use devices.

The Pipeline Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained cemented knee joint prosthesis. The system includes femoral components, tibial trays, biomimetic cruciate retaining (CR) tibial inserts, patellar components, and associated instrumentation. The tibial trays are manufactured from highly crosslinked vitamin E polyethylene. The patellar components are manufactured from vitamin E polyethylene. The CR inserts are designed for use when the posterior cruciate ligament is intact. The Pipeline Total Knee System femoral component, when used with the Pipeline Knee System articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The NEO™ PS Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with excised posterior cruciate ligament, undergoing surgery for total knee replacement due to: . Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis. . Failed osteotomies, partial knee replacement, or failed prior total knee replacement whose age, weight and activity level are compatible with an adequate long-term result. . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. . Moderate valgus, varus, or flexion deformities. NEO™ PS Total Knee System components are indicated for use only with cement and are single use devices.

The NEO PS Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation: The Neo PS Knee System femoral component, when used with the Neo PS articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The NEO CR Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing surgery for total knee replacement due to: - Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis. - Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. Neo CR Knee System components are indicated for use only with cement and are single use devices.

The NEO CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial trays, patellar components and surgical instrumentation. The Neo CR Knee System femoral component, when used with the Neo CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing total knee replacement due to: - . Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis. - Failed osteotomies, failed partial knee replacement, or failed prior total knee . replacement whose age, weight and activity level are compatible with an adequate long-term result. - . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. . Pipeline CR Total Knee System components are indicated for use only with cement and are single use devices.

The Pipeline Primary CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation. The Pipeline CR Total Knee System femoral component, when used with the Pipeline CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

Pipeline 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, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia; - Acute traumatic fracture of the femoral head or neck; - - Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement. The Pipeline Total Hip System is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The Pipeline Total Hip System is an artificial hip replacement system comprised of femoral stems and mating metal heads; acetabular shells and mating acetabular liners; optional acetabular bone screws; and optional acetabular dome hole occluders. The Pipeline Femoral Stems are forged titanium alloy, feature a proximal roughened surface (plasma-sprayed CP Titanium), come in a range of sizes, and are offered in two offset neck options per size. The Pipeline Femoral Heads are polished cobalt chromium alloy and come in a range of diameters and extension options. The Pipeline Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface (titanium alloy). The shells feature a dome hole, are available with or without a cluster screw hole pattern for supplemental bone screw fixation, and come in a range of outer diameter sizes. The Pipeline Acetabular Liners are manufactured from ultrahigh molecular weight polyethylene (standard UHMWPE or highly crosslinked Vitamin E UHMWPE). The liners are mechanically assembled to the mating shells via engagement of the liner taper with the shell bore. Locking is achieved through engagement of interrupted poly rib at the taper to sphere transition of the liner with a mating groove on the shell. Poly tabs of the liner mate with scallops on the face of the shell to prohibit rotation of the liner. The liners are available in a range of sizes, and are available in neutral, high wall, +4mm offset, +4mm offset/10° elevated, and +4mm offset/high wall options. Optional components include a threaded acetabular dome hole occluder and acetabular bone screws, all manufactured from titanium alloy.