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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".

For E-XPE Cup Liner and U-Motion II Acetabular Cup The device is used for reduction or relief of pain and/or improved hip function in sketally mature patients with the following conditions: 1. Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results. 4. Correction of functional deformity. 5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques. This device is a single use implant and intended for cementless use only. For E-XPE Cemented Cup 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, and painful hip dysplasia: 2. Inflammatory degenerative joint disease such as rheumatoid arthritis; 3. Correction of function deformity; 4. Revision procedures where other treatments or devices have failed; 5. Treatment of nonunion and femoral neck fractures of the proximal femur with head involvement that is unmanageable using other techniques. This device is a single use implant and intended for cemented use only.

For E-XPE Acetabular Components The subject E-XPE Acetabular Components includes U-Motion II E-XPE Cup Liner and E-XPE Cemented Cup. U-Motion II E-XPE Cup Liner includes 0° and 20° hood designs, which are available in 28 mm, 32 mm, 36 mm and 40 mm inner diameter (ID). The 28 mm liners fit the acetabular cups with outer diameter (OD) ranging from 44-46 mm, the 32 mm liners fit the acetabular cups ranging from 46-50 mm, the 36 mm liners fit the acetabular cups ranging from 50-70 mm, and the 40 mm liners fit the acetabular cups ranging from 56-70 mm. The E-XPE Cemented Cup is design for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The cement mantle is built within the outer surface of acetabular cup. The PMMA Spacer is designed for cement fixation with a uniform cement thickness and the X-ray marking wire is designed for X-ray image identification purpose. E-XPE Cemented Cups are available in a range of sizes to fit varying anatomical requirements. For U-Motion II Acetabular Cup The indication for use, materials, cup hole types, size distribution, sterilization method, safety and effectiveness of subject device are identical to predicate device (K122185) except the locking design. The subject device are available in sizes from 44 mm through 80 mm outer diameter in 2 mm increments.

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. - Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. - Press-fit femoral stems and acetabular cups are intended for press-fit fixation. - Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Exactech Novation and AcuMatch E-HXL Acetabular Liners are intended for use in total hip replacement as an interface between acetabular shells and femoral heads. Both Novation E-HXL Acetabular Liners and AcuMatch E-HXL Acetabular Liners are manufactured from Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol). The Novation E-HXL Acetabular Liners are available in five configurations (neutral, lipped, anterior lipped, +5mm lateralized, and 10 deg. face changing) with inner diameter ranging between 22mm and 40mm. The AcuMatch E-HXL Acetabular Liners are available in four configurations (0 deg., ext coverage, and +5mm lateralized) with inner diameter ranging between 28mm and 36mm. The overall design goals of the proposed Exactech Novation and AcuMatch E-HXL Acetabular Liners are to improve wear performance and provide oxidative stability in comparison to the predicate Exactech Novation and AcuMatch GXL Acetabular Liners.

The indications for the Trinity Acetabular System as a total hip arthroplasty include: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell, acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW, ceramic and Co-Cr modular heads and titanium femoral stems. The purpose of this submission is to add ECIMA acetabular liners to the Trinity Acetabular System. Corin's ECIMA is a cold irradiated, mechanically annealed, vitamin E blended ultra high molecular weight polyethylene.