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1) Noninflammatory 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 acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use. Indications for G7® Vivacit-E® Freedom® Constrained Liner: The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of distory of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7 Acetabular System currently offers a constrained Vitamin E infused highly crosslinked ultra high molecular weight polyethylene (UHMWPE) liner, branded E1 polyethylene, with a preassembled titanium alloy constraining ring. The constrained liner is designed for use in primary or revision total hip arthroplasty (THA) patients that are at a greater risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. Zimmer Biomet has designed and developed a new constrained liner for use within the G7 Acetabular System, the G7® Vivacit-E® Freedom® Constrained Liner. The purpose of this submission is to obtain clearance for this new constrained liner.

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. Acetabular shells and femoral stems with porous coatings are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use. Indications for Biomet G7™ Freedom™ Constrained Liners: The Biomet G7™ Freedom™ Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7™ Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. The titanium alloy (ASTM F136) shell is available in both a solid shell and limited hole design, with an apical hole and plug. The outer diameter of the shells is coated with Biomet's Porous Plasma Spray (ASTM F1580). The acetabular liners are manufactured from UHMWPE (ASTM F648) as ArComXL® or E1® (UHMWPE infused with vitamin E) and available in a Neutral, High Wall, or Ten Degree Face Changing design. Additionally, the system has provided for a constrained liner and head when such an option is required. The Biomet Freedom" product line has added a 32mm Freedom" head (cobalt chrome, ASTM F1537) to its offerings, as well as a new series of constrained liners (E1®, ASTM F648) designed for compatibility with the G7™ shells. A new line of cobalt chrome (ASTM F1537) femoral heads in varying sizes and neck lengths, with either a Type 1 or 12/14 taper, has been added to the system. The system is compatible with Biomet® ceramic heads and femoral stems.