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The VerSys Epoch FullCoat Hip Prosthesis is indicated for: - Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. - Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. - Patients suffering from disability due to previous fusion. - Patients with acute femoral neck fractures. This device is intended for cementless use only.

The VerSys Epoch FullCoat Hip stem is an addition to the currently marketed VerSys Epoch FullCoat proximal femoral hip implant family. It is a set of fully porous coated implants that are comprised of Zimaloy™, a cobalt chromium molybdenum (CoCrMo) alloy core surrounded by a layer of injection molded polyetheretherketone (PEEK) encased in a layer of commercially pure titanium fiber metal (FM). The stem is designed to replace the proximal femur in a total hip arthroplasty. It features a 12/14 Morse-type taper to accommodate the attachment of modular femoral heads. The proximal geometry of the device is trapezoidal and comes in two options Reduced Neck Length (RNL) with 125° and 135° angles and Low Head Center (LHC) with a 125° angle.

The PROFEMUR® RENAISSANCE™ Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - inflammatory degenerative joint disease such as rheumatoid arthritis; - correction of functional deformity; and, - revision procedures where other treatments or devices have failed

The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are summarized below: - Manufactured from titanium alloy (Ti6A14V) . - Offered in two medial flare options - 1mm increments from size 10-18 - Tri-planar proximal geometry with plasma sprayed surface or plasma sprayed surface with HA coating - Cylindrical, splined, and slotted distal stem with glassbead surface - Threaded hole with slot impaction mechanism . - Polished distal tip and collar

The CONSERVE® Total Femoral Head is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed The CONSERVE® Total Femoral Head is intended for single patient use only.

Manufactured from wrought cobalt-chromium-molybdenum . The articulating surface of the implants will be superfinished . Available sizes: 36mm, 38mm, 42mm, 42mm, 46mm, 48mm, 50mm, 52mm, 52mm, . 54mm, 56mm The taper connection is identical to previously cleared taper connections and is . intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

The M²a™/C²a™ Acetabular System is intended for cemented or non-cemented use in cases of: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Revision procedures where other treatment or devices have been unsuccessful 5) Treatment of non-union, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

The M²a™/C²a™ Acetabular System consists of a titanium outer acetabular shell with a cobalt alloy metallic liner for metal articulation. The acetabular shells are hemispherical in shape to closely match the natural acetabulum. Two screw holes in the dome allow for additional fixation by the use of screws. The outer surface of the shells are covered with Biomet's plasma sprayed coating. The metallic cobalt alloy bearing liner fits into the outer shell by means of a taper similar to the taper used for the attachment of a modular head to a femoral stem. The metallic liners articulate with cobalt alloy modular heads.

The PROFEMUR® S Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - inflammatory degenerative joint disease such as rheumatoid arthritis; - correction of functional deformity; and, - revision procedures where other treatments or devices have failed

The design features of the PROFEMUR® S Hip Stem are summarized below: - Offered in two medial flare options . - Modular neck taper . - Triplanar proximal geometry w/ plasma spray . - Splined, slotted, and cylindrical distal stem w/ grit blast . - Dimple with cross slot on lateral shoulder ● - Polished distal tip and collar .

The PROFEMUR® Tapered Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

The design features of the PROFEMUR® Tapered Hip Stem are summarized below: - Modular neck taper - Tapered cylindrical distal stem - Plasma Sprayed proximal body - Grit blasted distal stem - Polished bullet tip - Spines

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The Metal TRANSCEND® Articulation System components are for single use only.

The Metal TRANSCEND® Articulation System consists of components that are identical to the previously submitted components under the Metal TRANSCEND® Articulation System IDE: metal acetabular shells, metal acetabular liners, and metal femoral heads. Design features of the Metal TRANSCEND® Acetabular Shell are summarized below: - Manufactured from Ti6Al4V conforming to ASTM F-136 or ASTM F620 . - Porous coated with commercially pure titanium (ASTM F67 or F 1580) sintered . beads - Features three screw holes and an apical hole ● - Designed for use with Apical Hole Plug and bone screws . - Internal geometry of the shell features an 18.8750° (included) taper to accept . acetabular liners - Available in 12 sizes ranging from 46mm to 68mm in 2mm increments . Design features of the Metal TRANSCEND® Acetabular Liner are summarized below: - Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75 - Designed for use with metal acetabular shell . - Available in three inside diameters: 28mm, 32mm, and 36mm ● Design features of the Metal TRANSCEND® Femoral Head are summarized below: - Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75 - Available in three sizes: 28mm, 32mm, and 36mm . - Available in four neck lengths: short, medium, long, and extra-long ●