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- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Correction of functional deformities. - Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy. - Moderate valgus, varus, or flexion trauma. - Knee fractures untreatable by other methods. - Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only). The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation

The Freedom Total Knee System All-Poly Tibial Plate implants have been developed with the desire to expand upon the already clinically successful Freedom® Total Knee System, melding together the best design features of various sub-systems into one. The implants will retain the key benefits of the All-Poly Tibial implant system while leveraging some of the modular, metal-backed systems (K090411, K182574, K243277). Using the All-Poly design, the articular surface, tibial baseplate, and stem are manufactured from a single component. This eliming from modularity, reduces the overall weight and subsidence risk, adds full radiolucency to the tibial implants, and comes at a reduced cost. Like the original All-Poly Implants, these new versions will be manufactured from GUR 1020 (Type 1) UHMWPE per ASTM F648. To enhance the existing All-Poly Implant designs, the stem of these implants is being upgraded to the larger, finned stem/keel design from the modular Freedom® Total Knee System (K090411). This will provide the new All-Poly Tibial implanted stability post-operatively and allow surgeons to use the same instruments/surgical technique as the modular, metal-backed system. This will improve the harmony between the various Freedom® systems and ensure all produce the same strong clinical results.

The Freedom® Total Knee System is indicated for the following: • Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Correction of functional deformities. • Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods. • Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only). The Freedom® Porous Tibial Base Plate and Cementless Femoral Components are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.

The Freedom® Porous Tibial Base Plate is a line extension of the Freedom® Total Knee System comprising of tibial base plate components for cemented or uncemented use in total knee arthroplasty. Freedom® Porous Tibial Base Plates are intended for use with existing, compatible Freedom® femoral and tibial liner components. Freedom® Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom® Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.

The Freedom® Medial Congruent Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. The Freedom® Total Knee System is indicated for the following: - · Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis. - · Correction of functional deformities. - · Post-traumatic loss of knee ioin contour, particularly when there is patellofemoral erosion. - dysfunction, and/or prior patellectomy. - · Moderate valqus, varus, or flexion trauma. - · Knee fractures untreatable by other methods. The Freedom® Medial Congruent Tibial Liner is intended for cemented use only. This device is for single use only.

Freedom® Medial Congruent Liners have been developed with the desire to achieve a higher level of constraint than typically achieved in a traditional CR knee design while also providing the femoral component with a medial-pivoting motion throughout a range of motion. They possess an anterior and buildup and a higher sagittal conformity of the medial compartment that interact with the femoral component, to provide additional constraint. Designed to be used with the Freedom CR Femoral Component. Eliminates the need to remove bone for a PS box. Designed to allow high flexion. Includes a deep anterior patellar cut-out to allow for tendon clearance. Facilitates intraoperative flexibility, given compatibility with existing femoral and tibial baseplate options

The Freedom® - TiNbN Coated Knee is indicated for the following: · Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis. · Correction of functional deformities. · Post-traumatic loss of knee joint contour, when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. · Moderate valgus, varus, or flexion trauma. - · Knee fractures untreatable by other methods. · Revision surgery where sufficient bone stock and soft tissue integrity are present. The Freedom® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Freedom® - TiNbN Coated Knee comprises of Femoral Component and Tibial Component as described below, - Femoral Knee Component CR and PS (Left and Right) - Tibial Component (Tibial Base Plate) Each of these components is described below.

The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: - · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis. - · Rheumatoid arthritis. - · Congenital hip dysplasia. - · Acute traumatic fracture of the femoral head or neck. - · Certain cases of Ankylosis. - · Dislocation of the hip. - · Correction of functional deformity. - · Revision of failed joint reconstruction or treatment. - · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur. Note · The Modular Shell, Uncemented Stem and Taper Uncemented Femoral Stem are intended for press-fit, uncemented use only. · The Cemented stem is intended for cemented use only.

This 510k is intended to add a Modular Liner made from Vitamin E containing HXLPE (E-XLPE) to the Libertas™ - Hip Replacement System and Libertas™ Acetabular Hooded Liner cleared under K180973 and K183365, respectively. These Modular Liners are designed to be used with the Libertas components already cleared under K180973. These are available in different sizes i.e. MA, MB, MD, MF, MH, MJ, MK and different variants for each size Viz, neutral offset, "+4 mm offset", "Elevated wall", "10° Oblique", "15° Oblique" and "+4 mm offset 10° Oblique".

The Freedom® Primary PCK is designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System, and is indicated for the following: · Severe knee joint pain, loss of mobility due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. · Correction of functional deformities. · Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. - · Moderate valgus, varus, or flexion trauma. - · Knee fractures untreatable by other methods · Revision surgery where sufficient bone stock and soft tissue integrity are present The Freedom® Primary PCK is intended for cemented use only. This device is for single use only.

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The Libertas™ Acetabular Hooded Liner is intended for use in total hip arthroplasty, in conjunction with the Libertas™ Hip Replacement System. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: - · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis. - · Rheumatoid arthritis. - · Congenital hip dysplasia. - · Acute traumatic fracture of the femoral head or neck. - · Certain cases of Ankylosis. - · Dislocation of the hip. - · Correction of functional deformity. - · Revision of failed joint reconstruction or treatment. - · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

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The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. The Freedom® Total Knee System is indicated for the following: - Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis. - Correction of functional deformities. - Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. - Moderate valgus, varus, or flexion trauma. - Knee fractures untreatable by other methods. The Freedom® Ultra-Congruent Tibial Liner is intended for cemented use only. This device is for single use only.

The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System.

The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: - Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - Congenital hip dysplasia. - Acute traumatic fracture of the femoral head or neck. - Certain cases of Ankylosis. - Dislocation of the hip. - Correction of functional deformity. - Revision of failed joint reconstruction or treatment. - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur. NOTE: - The Modular Shell and Uncemented Stem are intended for press-fit, uncemented use only. - The Cemented stem is intended for cemented use only.

The Libertas™ Hip Replacement System consists of the following components: - Acetabular Cup System - Modular Shell - Modular Liner HXLPE - Cobalt Chromium alloy Modular Femoral Head - Biolox® delta Modular Femoral Head - Femoral Stem - Uncemented Femoral Stem - Cemented Femoral Stem - Accessories (Sub components) - Bone Screw - Apical Hole Occluder - Centralizer - Cement Restrictor - Screw Hole Occluder

The Freedom® Cementless Femoral Components are designed to be used as a part of the Freedom® Total Knee System, and is indicated for the following: - Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Correction of functional deformities. - Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. - Moderate valgus, varus, or flexion trauma. - Knee fractures untreatable by other methods - Revision surgery where sufficient bone stock and soft tissue integrity are present. ● The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation. Only Cementless Femoral (CR and PS) components with porous coating are additionally indicated for cementless biological fixation application.

The Cementless Femoral Components ("Components") are intended for use with the currently available Freedom Total Knee System as part of total knee replacement (TKR) surgery. Total knee replacement surgery is a procedure where worn, diseased, or damaged surfaces of the knee joint are removed and replaced with artificial surfaces. The Components will be prescription products consisting of single use only, implantable devices for implanting into patients in an operating theatre by a qualified surgeon.