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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® Total Knee System – Titanium Tibial Base Plate is intended for cemented and single use only.

The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. The Freedom® Total Knee System was originally cleared under the 510(k) number K082019. Later on, several modifications were made and were cleared under 510(k)s K091280, K192148, K090411, K182574, K131481, K111785 and K200912 respectively. The primary purpose of this special 510(k) Device Modification to the Freedom® Metal Backed Tibial Component (K090411) is to notify the FDA of the change in materials used to manufacture the tibial base plate from CoCrMo to Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) as an alternative material option for the tibial base plate. The Titanium Tibial Base Plate is fabricated from Titanium alloy Ti-6Al-4V ELI, compliant with ASTM F136 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Titanium Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

The Freedom® Total Knee System is indicated for patients with severe knee pain and the disability due to: · 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. The Freedom® Total Knee System is intended for cemented and for single use only.

The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. This submission seeks the clearance of Titanium Nitride (TiNbN) coated version of previously cleared Stemmed PCK Femoral Component (non-coated version cleared in K131481) and Stemmed Tibial Base Plate (non-coated version cleated in K111785). The coated versions are now branded as Titan PCK Stemmed Femoral Component and Titan Stemmed Tibial Base Plate. Both these components are manufactured from CoCrMo alloy and are coated completely with Titanium Niobium Nitride (TiNbN).

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, post traumatic arthritis 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 stem are intended for press-fit, uncemented use only. - · The Cemented stem is intended for cemented use only.

The Libertas™ - Taper uncemented femoral stem is fabricated from Ti6Al4V - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Libertas Femoral heads, previously cleared under K180973. The proximal portion of stem is coated with commercially pure Titanium with plasma spray method. Libertas™ - Taper uncemented femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).