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Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use - 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. Rough grit blast surfaces are intended for uncemented arthroplasty. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.

Design features of the subject stems are summarized below: - Cementless modular stems - Available in 9 sizes - Manufactured from Titanium alloy with a heavy grit blasted surface. The subject device is available in 9 sizes (from size 3 to 11). Although the proximal geometries are identical to the predicate from size 3-9, the distal stem length has increased, with two larger sizes (10 and 11) introduced.

The DYNASTY® BIOFOAM® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use - 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 DYNASTY® BIOFOAM® Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below: - Shells manufactured from Titanium alloy substrate, coated with BIOFOAM® coating manufactured from commercially pure (CP) titanium - Solid shell sizes: 46mm-68mm outer diameter - Three different hole patterns: - 10-hole shell sizes: 46mm-76mm outer diameter - 3-hole shell sizes: 46mm-68mm outer diameter - 5-hole shell sizes: 46mm-50mm outer diameter The DYNASTY® BIOFOAM® Shells are identical to previously cleared devices, except that the subject device posses different screw hole patterns. Additionally, the DYNASTY® BIOFOAM® Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results indicates that the DYNASTY® BIOFOAM® Shells are equivalent to predicate devices.

Biomet Metal-On-Metal Total hip replacement components are intended for either cemented or uncemented use to replace the articulating portions of the hip during total hip arthroplasty. Indications For Use: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-RinglocTM). (b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™). 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. The components of the M2a-Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

Metal-On-Metal Hip prosthesis components provide for total hip replacement with a direct metal to metal articulation. They consist of a series of metal femoral head prostheses (either monolithic or modular) that articulate with highly congruent mating acetabular components without the need for a ceramic or polyethylene liner. This submission is intended to notify FDA that Biomet has included additional Contraindications to the labeling for Metal-On-Metal total hip prosthesis components to assure the safe and effective use of Biomet Metal-On-Metal components for the appropriate patient populations. These changes are incorporated into one IFU that will be applicable for all Metal-On-Metal components currently cleared by FDA.

The CONSERVE® Thin Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use - non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia; - inflammatory degenerative joint disease such as rheumatoid arthritis; 2. - 3. correction of functional deformity; and, - revision procedures where other treatments or devices have failed 4. The CONSERVE® Thin Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below: - Monoblock acetabular cup . - . Available in 12 sizes - Manufactured from CoCr alloy with a CoCr porous bead coating . The CONSERVE® Thin Shells are identical to previously cleared devices, except that the subject device does not possess HA coating. Additionally, the CONSERVE® Thin Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results indicates that the CONSERVE® Thin Shells are equivalent to predicate devices.

The Preserve Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use: 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 Preserve hip stem is intended for cementless hip arthroplasty.

The Preserve stems are short modular hip stems that couple with modular necks. Design features of the stems are summarized below: - . Cementless stem with proximal cpTi plasma spray coating - Available in 9 sizes (4-12) - Manufactured from Ti alloy The Preserve Hip Stems were evaluated via mechanical testing; including fatigue, fretting; and distraction evaluation. A review of these results indicates that the Preserve Hip Stems are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

The PROFEMUR® GLADIATOR® HA Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use: 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 PROFEMUR® Gladiator HA Hip Stem is intended for cementless hip arthroplasty.

The PROFEMUR® GLADIATOR® HA stems are hydroxyapatite coated hip stems that couple with modular necks. Design features of the stems are summarized below: - Cementless stem with hydroxyapatite plasma spray coating - Available in 10 sizes - Manufactured from Ti alloy (Ti-6Al-4V) conforming to ASTM F620 - Hydroxyapatite coating conforming to ASTM F1185 - Available with and without collar

The PMMA Distal Centralizers are intended 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 PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.

The PROFEMUR® X" Wingless Distal Centralizer and PERFECTA® Distal Centralizer are molded PMMA centralizers placed within the femoral canal before the hip stem implant, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The materials used for the Distal Centralizers are identical to the materials used for the predicate devices (molded PMMA), but unlike the predicate the replacement will not contain any additives.

The Gladiator Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use: 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 Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty. The Cemented hip stem is intended for cemented hip arthroplasty.

The Gladiator stems are modular hip stems that couple with modular necks. Design features of the stems are summarized below: - Cementless stem with proximal cpTi plasma spray coating. - Available in 10 sizes - Manufactured from Ti alloy - Cemented - Available in 5 sizes - Manufactured from CoCr alloy - Distal centralizers available

Total hip replacement for patients with: - Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, . osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - . Femoral neck fractures. - . Failed previous surgery where pain, deformity, or dysfunction persists. - Revision of previously failed hip arthroplasty. . Hemi-hip replacement for patients with: - Femoral neck fractures. . This femoral stem is for cementless use only.

The CLS Brevius Stem with Kinectiv Technology is a modular, titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design with a proximal-to-distal taper and a trapezoidal cross-section. The proximal portion of the stem contains a tapered female junction to allow for attachment to Kinectiv Technology modular necks and features for attachment of insertion/extraction instrumentation.

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Porous coated components are intended for uncemented biological fixation.

The TaperIoc® Complete Microplasty Stems are an update to the existing TaperIoc® Microplasty Stems and are designed to replace the patient's natural hip, femoral neck, and head, due to disease or accident. The Taperloc® Complete Microplasty Stems will combine the design features of the Taperioc® Complete full-length stems to the shortened design of the existing Taperloc® Microplasty Stems. These design features include: a reduced neck angle, shorter/longer neck lengths, reduced Type 1 taper geometry with neck flats, polished neck, standard and high offset versions, two distal profiles, and an updated insertion hole. Stem sizes ranges are within the ranges of legally marketed predicates. The substrate material is Ti-6AI-AV, ASTM F-136. The proximal intramedullary region is sprayed with porous plasma spray.