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Indications for use of the ConsensusTM Hip System or UNISYN™ Hip System - A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. - C) Proximal femoral fractures. - D) Avascular necrosis of the femoral head. - E) Non-union of proximal femoral neck fractures. - F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa vara, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

The Consensus Hip 36mm CoCrMo (ASTM F799 or ASTM F1537) femoral head is offered with four different offsets, -5mm, neutral, +5mm and +10mm. Other than size, it incorporates no new design features. Female head taper is identical to the head taper design for the cleared devices. The 36mm acetabular insert is offered in sizes 54 - 68 (2 mm increments), in neutral, 10 and 20 degree hooded configurations. Material for all 36mm insert sizes is crosslink UHMWPE (ASTM F648). Hooded configurations incorporate a titanium alloy x-ray marker (Ti 6Al-4V ELJ ASTM F136). Insert locking detail of the subject device is identical to the locking detail of the cleared devices.

Indications for use of the UNISYN™ HIP SYSTEM A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis. B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. C) Proximal femoral fractures. D) Avascular necrosis of the femoral head. E) Non-union of proximal femoral neck fractures. F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities

The Body, HA Plasma, Modular Hip is part of the Unisyn modular hip system. The system consists of three parts; the neck, the body, and the stem. There are thirty-three different proximal bodies with six different cone diameters with multiple medial projections for each size. There are also cone-only bodies with and without collars. The surface of the body is plasma sprayed with a secondary coating of hydroxylapatite.

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: - Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. . - Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. . - . Proximal femoral fractures - . Avascular necrosis of the femoral head - . Non-union of proximal femoral neck fractures - Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa ● vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomaliacia, osteoporosis, pseudarthrosis conversion and structural abnormalities.

The Consensus Acetabular Shell System consists of four modular shell options which mate with currently marketed polyethelyne insert components for replacement of the acetabular surface during total hip arthroplasty. The shells are designed to be implanted without bone cement. Cementless (press-fit) fixation is achieved by coating the external surface of the cup with commercially pure (CP) titanium sintered beads. All of the shell options have the following common features: - The substrate material of the Consensus Shells is titanium alloy (ASTM F136, Ti-6AI-4V) ● - · The shell is porous coated with commercially pure (CP) titanium sintered beads (ASTM F67, irregular bead geometry). - · The shells have the same internal locking mechanism as the previously cleared Consensus Acetabular Shells (K922561). - · The apical dome hole of the shells is threaded to accept an impaction tool for implanting the component. After implantation and the impaction tool is removed, a threaded titanium (ASTM F67 or F136) hole plug can be inserted into the threaded hole to prevent migration of unwanted particles through the dome hole. The following shell options are available: - · Total Hemispherical in no screw holes or three (3) quadrant screw holes options. - · Hemispherical with rim flare in no screw holes or three (3) quadrant screw holes options.

The 32 mm ceramic femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. The indications for use are: With Consensus® System: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck. 2. Osteoarthrosis involving femoral and acetabular articular surfaces. 3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures. 4. Fracture or dislocation of the hip. 5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists. With UniSyn® System: 1. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. 2. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. 3. Proximal femoral fractures. 4. Avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. 7. Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life.

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The cobalt-chrome unipolar femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. The indications for use are: With Consensus® System: - A) Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck. - B) Osteoarthrosis involving femoral and acetabular articular surfaces. - C) Avascular osteonecrosis and/or non-union of acute femoral neck fractures. - D) Fracture or dislocation of the hip. - E) Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists. With UniSyn® System: - A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. - C) Proximal femoral fractures. - D) Avascular necrosis of the femoral head. - E) Non-union of proximal femoral neck fractures. - F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. - G) Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life

The cobalt-chrome unipolar femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems.

The cross-linked polyethylene acetabular insert is design for use with the Consensus or UniSvn ® Hip Systems, and is not intended for substitution with components of other systems. The indications for use are: With Consensus® System: - A) Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck. - B) Osteoarthrosis involving femoral and acetabular articular surfaces. - C) Avascular osteonecrosis and/or non-union of acute femoral neck fractures. - D) Fracture or dislocation of the hip. - E) Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists. With UniSyn® System: - A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. - C) Proximal femoral fractures. - D) Avascular necrosis of the femoral head. - E) Non-union of proximal femoral neck fractures. - F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. - G) Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life.

Cross Linked Polyethylene Acetabular Insert

The Ti coated porous acetabular shell is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. The device is intended primarily for uncemented, press-fit applications. The indications for use are: With Consensus® System: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck. 2. Osteoarthrosis involving femoral and acetabular articular surfaces. 3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures. 4. Fracture or dislocation of the hip. 5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists. With UniSyn ® System: 1. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. 2. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. 3. Proximal femoral fractures. 4. Avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. 7. Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple ioint involvement, for whom restoration of ioint mobility leads to an expectation of greater mobility and an improvement in the quality of life.

Acetabular Shell, Porous Ti TI Coating

The Consensus® Knee System and the CoCr/Ti porous or CoCr nonporous tibial baseblate is design for use as a system, and is not intended for substitution with components of other systems. This device is intended for cemented use only. The indications for use are: - Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis. - Failed osteotomy or unicompartmental replacements. - Replacement of unsatisfactory cemented or press fit knee components, if sufficient bone stock exists.

Tibial Baseplate, Cast, CorCr/Ti Porous and CoCr Non-Porous

The Consensus® CoCr/Ti Femoral Component is intended for use with the Consensus® Knee System and is not intended for substitution of components from other systems. This device is intended for cemented use only. The indications for use are as follows: - Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis; - Intervention of failed osteotomies and unicompartmental replacements; - Replacement of unsatisfactory cemented or press fit knee components if sufficient bone stock exist.

The porous femoral knee component will be available in a left and right configuration and is designed to replicate the natural anatomy of the femur. The design of the femoral component incorporates a swept-back radius on the outer condyle surfaces to allow for smooth articulation throughout the range of motion. The outer articular surface of the femoral component will also have a deepened trochlear groove to allow for more anatomic tracking of the patellar component and improved range of motion. The material will be cast CoCrMo alloy (ASTM F75-92). The inner box geometry of the femoral component is designed to allow a minimum bone resection of 10mm distal, 9mm posterior, and 6.5mm anterior. The anterior flange of the femoral component is angled 4°outward, posterior to anterior, to reduce the potential for notching the anterior femur. The anterior flange will also incorporate a stepped chamfer which allows for positioning the trochlear groove in a more anatomic position. A smooth tapered peg will be located on each distal condyle to provide medial-lateral stability and enhanced fixation. The surfaces of the inner box geometry of the porous femoral component will incorporate a sintered porous coating of CoCr beads (ASTM F75-92), which will subsequently be coated with Titanium alloy (ASTM F67-95). The porous coating is designed to enhance cement fixation.