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The Anato™ Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi-hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' V40™ femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40130 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40™ CoCr Heads, V40™ LFITM CoCr Heads, C-Taper Alumina Heads when used with the V40TM /C-taper Adapter, C-Taper Delta Heads when used with C-taper Adaptor, UHR® Universal Head, Unitrax® Heads when used with the Unitrax® V40™ Modular Adapter. The indications for use for total hip arthroplasty include: - noninflammatory degenerative joint disease, including osteoarthritis . and avascular necrosis; - rheumatoid arthritis; . - correction of functional deformity; . - revision procedures where other treatments or devices have failed; and, ● - nonunions, femoral neck fractures, and trochanteric fractures of the . proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of Anato™ Hip Stem with compatible Howmedica Osteonics Constrained Liners: - When the stem is to be used with compatible Howmedica Osteonics . Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.

Howmedica Osteonics is introducing a monolithic, non-porous coated femoral hip prosthesis, which is intended for cementless, press-fit application. The basic design of the Anato™ Hip Stem is similar to two other commerically distributed total hip systems, which are Howmedica Osteonics' ABG® II Monolithic and Accolade® II Hip Stems. The Anato™ and the Accolade® II stem are both made from the same material combinations. The subject device is similar in design to the ABG® II Monolithic stem as they are both anatomic stems with a 130 degree neck angle. There are normalization patterns (scales) on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission. Based on 3-Dimensional simulations, these normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading. The subject stem is manufactured from titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium coating, and PureFix® hydroxylapatite (HA) coating identical to the previously cleared Accolade® II Hip Stem. The Anato™ Hip Stem has a shot peened neck and will be available in 8 sizes ranging from size 1 through 8 with two different neck versions (neutral and anteverted). As the stem is anatomic, there will be a right and left component for each size. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.

The indications for use for total hip arthroplasty include: - noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; - rheumatoid arthritis; - correction of functional deformity; - revision procedures where other treatments or devices have failed; and, - nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of ABG™ II Monolithic Hip Stem with compatible Howmedica Osteonics Constrained Liners: - When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability. The Stem is intended for cementless, press-fit use only and is intended for total and hemiarthroplasty procedures'.

Howmedica Osteonics is introducing a monolithic femoral hip prosthesis. The basic design of the ABG™ II Monolithic Hip Stem, referred as the ABG™ II, is similar to other total hip systems commercially distributed such as the Stryker ABG™ II Modular Hip System. The subject hip stem is a TMZF (Ti-11.5 Mo-6Zr-2Fe) alloy femoral stem with a roughened hydroxylapatite coating in the proximal region. It is intended for cementless, press-fit application and designed for use with the currently available compatible Howmedica Osteonics' femoral heads, bipolar heads, and their compatible acetabular components. The ABGTM II Monolithic Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter. The ABGTM II Monolithic Hip Stem will be available in 8 sizes ranging from size 1 through 8 with one neck angle of 130°. The ABG™ II Monolithic Hip Stem anatomic stem is made with 12° of anteversion built into the proximal portion of the stem.

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 using other techniques. 5. Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications (as based on mating shell)

Biomet Manufacturing Corp. is adding new +3 MaxRom™ and +3 Hi-Wall profiles to allow the surgeon an option for achieving more range of motion and joint stability in smaller patients.

The Equator Plus™ Acetabular Cup System has the following indications for use: - The patient should be skeletally mature. - The patient's condition should be due to one or more of the following: 1. Osteoarthritis. 2. Rheumatoid arthritis. 3. Tumor conditions involving the upper third of the femur or of the Acetabular. 4. Ankylosing spondylitis. 5. Psoriatic arthritis. 6. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein. 7. Non union of femoral neck fracture or avascular necrosis of the femoral head. 8. Post-traumatic fracture/dislocation of the hip. 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling. 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present. 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.