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NovoHip Vitamin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis or traumatic arthritis - Correction of functional deformity - Non-union femoral neck fracture - Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques. The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral head, acetabular liner, and acetabular shell components. The femoral head component articulates within the poly acetabular component. The acetabular liner snaps into the acetabular shell component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion. The NovoHip Vitamin E liners are components to be used with the NovoHip Total Hip System, previously cleared via K132158. The Vitamin E poly acetabular component snaps into the metal acetabular components that were previously cleared with the NovoHip Total Hip System.

NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis or traumatic arthritis - Correction of functional deformity - Non-union femoral neck fracture - Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques. The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion. The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The unipolar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes. The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offered with different inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components. The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.

The NovoKnee 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 NovoKnee 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 NovoKnee Total Knee System is designed for cemented use only.

The present 510k submission is for a cruciate retaining (CR) version of the NovoKnee Total Knee System. The main predicate device (K123339) is a posterior stabilized (PS) version of the NovoKnee Total Knee System. All implant components are the same between the two versions, except for the tibial inserts and the femoral components. The posterior stabilized version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The cruciate retaining version of the NovoKnee Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The NovoKnee Total Knee System is a Patellofemorotibia, polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size fernoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.

The NovoKnee 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, 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 NovoKnee 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 NovoKnee Total Knee System is designed for cemented use only.

The NovoKnee Total Knee System is of the fixed bearing type with a posterior stabilized design. It is a Patellofemorotibia, polymer/metal/polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.