Search Results

The Apex Modular™ HA Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: - Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; - Rheumatoid arthritis; - Correction of functional deformity; - Congenital dislocation; - Revision procedures where other treatments or devices have failed; - Femoral neck and trochanteric fractures of the proximal femur.

The Apex Modular™ HA Hip Stem consists of three modular components, with various sizes available for each component: the porous coated femoral stem, a modular neck that connects to the proximal end of the femoral stem, and a modular head that connects to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular HA Hip Stem may be used in conjunction with the Apex Modular Acetabular Cup (K031110) for total hip arthroplasty. The femoral stems (and modular necks) are manufactured from titanium alloy. The Apex Modular HA stems can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray, with an optional hydroxyapatite (HA) coating on top of the titanium coating. As in the predicate Apex Modular stem, the alignment pin in the stem is manufactured from wrought cobalt chromium alloy.

The Apex K2™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: - . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; - . Rheumatoid arthritis; - Correction of functional deformity: . - Congenital dislocation; . - Revision procedures where other treatments or devices have failed; . - . Femoral neck and trochanteric fractures of the proximal femur.

The Apex K2™ Hip Stem consists of a rectangular tapered stem, modular necks that connect to the proximal end of the stem, and the modular heads that connect to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex K2 Hip Stem may be used in conjunction with the Apex Modular Acetabular Cup (K031110) for total hip arthroplasty. The femoral stems (and modular necks) are manufactured from titanium alloy. The Apex K2 stems can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular hip system. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray, the same coating method used by the predicate Apex Modular hip stem. As in the predicate Apex Modular stem, the alignment pin in the stem is manufactured from wrought cobalt chromium alloy.

The Apex Modular™ Acetabular Cup is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: - Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; - Rheumatoid arthritis; - Correction of functional deformity; - Congenital dislocation; - Revision procedures where other treatments or devices have failed; - Femoral neck and trochanteric fractures of the proximal femur.

The Apex Modular™ Acetabular Cups are manufactured of titanium alloy, with a sintered bead porous coating (commercially pure titanium, irregular bead geometry). The liners are manufactured of ram extruded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or ceramic, 28 or 32 mm diameter, with various offsets.

The Apex Modular™ Alumina Femoral Head is intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: - Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis; - Rheumatoid arthritis; . - Correction of functional deformity; . - Congenital dislocation; . - Revision procedures where other treatments or devices have failed; . - Femoral neck and trochanteric fractures of the proximal femur. ●

The Apex Modular™ Alumina Heads are manufactured of Biolox® forte alumina (high purity aluminum oxide ceramic) by CeramTec AG (Biolox® is a registered trademark of CeramTec AG). The bore on this ball was designed and tested for compatibility with the neck taper on the Apex Modular Hip Stem (K000788). These modular heads are available in 28 mm and 32 mm diameters, with three offset options for each head size: -3.5, 0, and +3.5 mm (28 mm diameter heads) and -4, 0, and +4 mm (32 mm diameter heads).

The Apex Modular™ Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: - Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis: - . Rheumatoid arthritis: - Correction of functional deformity; . - Congenital dislocation: . - Revision procedures where other treatments or devices have failed; . - . Femoral neck and trochanteric fractures of the proximal femur.

The Apex Modular Hip Stem consists of three modular components, with various sizes available for each component: the porous coated femoral stem, a modular neck that connects to the proximal end of the femoral stem, and a modular head that connects to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. The modular heads are available in standard diameters so as to fit appropriate commercially available acetabular components of the surgeons' choosing. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular Hip Stem may be used in conjunction with the Link® SPII® Acetabular Cup for total hip arthroplasty. The femoral stem and neck components are manufactured from titanium alloy, and the head components are manufactured from wrought cobalt chromium alloy, the same materials used to manufacture the predicate hip stems and heads, respectively. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray. The alignment pin in the femoral stem is manufactured from wrought cobalt chromium alloy.