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A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. B. Failed osteotomy or unicompartmental replacements. C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement. E. The porous coated (CoCr beads with Titanium) components may be used with or without cement. F. Stemmed baseplates of the CKS Plus Knee System are intended for cemented use only

The CKS Plus extension to the Consensus Knee System (CKS) is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw, tibial intramedullary (IM) stem fixation, and tibial augments

The PS2 KNEE SYSTEM is designed as a system and is not intended for substitution of components from other systems. The indications for use are: - A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. - B. Failed osteotomy or unicompartmental replacements. - C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. - D. The PS2 KNEE SYSTEM is intended for cemented use.

The PS2 Knee System is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw and tibial stem fixation. The uncoated femoral components (CR and PS) and uncoated tibial baseplates (pegged, pegless, and holed) are made from cast CoCr alloy (ASTM F75), and are intended for cemented use only. The tibial inserts (CR and PS) and all-poly patellar components (oval and round) are made from UHMWPE (ASTM F648) or VitalitE (ASTM F2695). The PS2 tibial baseplate employs a modular keel, which is compatible with the previously cleared Consensus Revision Knee System (CRKS) stem and taper plug made from Titanium alloy (ASTM F1472). The PS2 holed baseplate is compatible with the previously cleared Consensus Knee System (CKS) 6.5mm cancellous bone screw made from Titanium alloy (ASTM F136). The PS2 baseplate is supplied with four preassembled cement dams made from UHMWPE and supplied with a distal plug made from UHMWPE intended for assembly in the operating room when stems are not desired.

When used with the components of the Consensus Knee System: The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems. - A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. - B. Failed osteotomy or unicompartmental replacements. - C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. - D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement. - E. The porous coated (CoCr beads with Titanium) components may be used with or without cement. When used as a component of the Consensus Revision Knee System: The Consensus® Revision Knee System is designed as a system and is only intended to be used with compatible components of the Consensus® Knee System. The revision knee femoral and tibial components are intended for cemented use only. The indications for use are: - A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle. - B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion. dvsfunction, or prior patellectomy) - C. Failed osteotomy or unicompartmental replacements. - D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. - E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery - F. Moderate valgus, varus, or flexion deformities

The VitalitE Tibial Insert is a vitamin E version of the UHMWPE tibial insert that has been a component of both the Consensus Knee System (CKS) and the Consensus Revision Knee System (RKS). The new insert still serves as the gliding surface between the metallic femoral component and the metallic tibial base plate of these knee systems. The new VitalitE insert will also be available in a cruciate retaining (CR) or ultra-congruent/ PCL substituting designs in sizes 0 through 6 and in thicknesses from 10 to 22 mm. The proprietary locking mechanism design on the underside of the insert will remain unchanged. The only difference will be the vitamin E additive in the UHMWPE which is a-tocopherol. This is the exact same polymer that is used in the Consensus VitalitE Acetabular insert but with a slightly lower radiation dose. Consensus will also offer our current CKS all-poly patellae in the new vitamin E UHMWPE material. This includes both the round and oval configurations with either a 7.5 mm or 10 mm thickness.

The VitalitE Acetabular Insert for the Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications: 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 plana, 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, TaperSet, and CS2 femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

The Consensus CS2™ Acetabular Cup System consists of a titanium alloy shell (ASTM F620 or F136) and a polyethylene liner (ASTM F648). The system is compatible with the femoral components of all cleared hip systems manufactured by Consensus Orthopedics, Inc.: Consensus Hip System (CHS), TaperSet Hip System (THS), CS2 Hip System (CS2HS), and UniSyn Hip System (UniSyn). The CS2 Acetabular Cup System can be used with the CoCr, zirconia, or Biolox delta femoral heads currently marketed by Consensus and with 22mm, 32mm, and 36mm inner diameters. The liners are available in either neutral or hooded versions and with either standard or lateral offsets. The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The shell comes with or without holes for additional screw fixation. The new acetabular liners will be made from UHMPWE that contains vitamin E (a-tocopherol).

The CS2TM Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The indications for use are: - 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 plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural. abnormalities This CS2TM hip stem is indicated for cementless use. Indications for Use of the CONSENSUS® BIPOLAR or UNIPOLAR: - A. Primary replacement of the femoral head and neck with very little if any acetabular degradation noted. - B. Rheumatoid, osteo, and post traumatic arthritis. - C. Proximal femoral fractures. - D. Avascular necrosis of the femoral head. - E. Non-unions of proximal femoral neck fractures. - F. Revision of failed total hip arthroplasty. - G. Treatment of malunion or nonunion acetabular fractures. The CONSENSUS® BIPOLAR or UNIPOLAR are intended for cementless use.

The Consensus CS2TM Hip System (CS2HS) is a monolithic; titanium alloy fit & fill hip stem design with a proximal, plasma sprayed, porous CPTi coating. The stem has a cylindrical geometry with a bullet tip and is available in sizes designated as 10 mm to 22 mm. The stems feature a neck shaft angle of 128° and a 12/14. Morse taper trumilon. The stems are available with, or without a collar. The CS2 Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is. compatible with previously cleared CoCr heads, zirconia heads, Biolox delta heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.

Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. A. Proximal femoral fractures. B. Avascular necrosis of the femoral head. C. Non-union of proximal femoral neck fractures. D. 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. UNISYN stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN stems used with plasma/HA or HA coated bodies are intended for uncemented use only.

The UniSyn Hip System was originally cleared as a modular hip system for Hayes Medical under the name "Triton", modifications to the system were cleared in a subsequent submission by Hayes under the UniSyn name. Hayes Medical changed its name to Consensus Orthopedics in 2008. This system consists of three primary components: the neck, the body, and the stem. This submission is to addition of a set of modified ("Plus") stems. These minor modifications in body thickness are designed to allow for better contact between the implant and the inner surface of the medullary canal during revision surgery. The sizes of stems offered with the modified design are within the ranges previously cleared for the UniSyn system. The Plus stems are offered in neutral or +1 mm styles, short or long, in 10 to 20 mm diameters, and lengths from 110 to 210 mm. There is no change to the manufacturing, packaging, or sterilization processes. This change will not affect the indications for use nor any of the labeling.

The TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The indications for use are: - 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 plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The TaperSet™ hip stem is indicated for cementless use.

The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CP Ti coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes currently designated as 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. The TaperSet Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is compatible with previously cleared CoCr heads, zirconia or Biolox delta ceramic heads, unipolar heads, bipolar heads. UHMWPE inserts and acetabular cups. The modification addressed here is the addition of two stems in sizes 5mm and 6mm. The new stems are manufactured from forged titanium alloy (Ti-6AI-4V ELI, ASTM F620) and the proximal portion of the femoral stem component is plasma sprayed with commercially pure titanium (C. P. Ti. ASTM F1580). The new femoral stems are available in both standard and 7mm lateralized options and have the identical neck and taper design, and porous coating as the predicate TaperSet stems cleared under K102399 in design and indications.

The TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The indications for use are: - 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 plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The TaperSet™ hip stem is indicated for cementless use.

The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CPTi coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes designated as 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. The TaperSet Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is compatible with previously cleared CoCr heads, zirconia or Biolox delta ceramic heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups. The modification addressed here is the addition of a line of stems with a reduced distal profile (RDP) in sizes 10.5mm to 24mm.

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems. - A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. - B. Failed osteotomy or unicompartmental replacements. - C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. - D. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since the mid-1990's. The CKS has been designed to replicate the natural anatomy of the knee in order to restore knee function. It has been developed to preserve and utilize healthy ligamentous structures. For cases where the soft tissues are not functional, the PCL substituting tibial inserts or the posterior stabilized system are available for increased stability. The CKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The CKS can be used for total knee replacement with posterior cruciate ligament (PCL) retaining or substituting. The femoral components are provided in left and right side versions and are designed to replicate natural kinematic motion between the femur, tibia and patella. The Consensus femoral component is designed to provide uniform contact zones in the coronal plane throughout the range of motion when the knee is properly aligned. The femoral component is also designed with a large distal radius to optimize contact areas and reduce contact stress. The trochlear groove in the femur is designed to allow the load from the patella to be evenly distributed on the femur with adequate lateral constraint. The CKS metallic components are available in non-porous and porous coated variants for cemented use and in a porous coated (CoCr beads with Titanium) version for uncemented use.

The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications. The general indications for use are: - 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 plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.

The Consensus hip systems are semi-constrained, hip prosthesis designed for either The Consensuring bio surgery. They include the Consensus® Hip System (CHS), the Unisyn™ Hip System, and the TaperSet™ Hip System (THS). All three hip systems utilize the exact same 12/14 Morse taper trunnion. These hip stems are compatible with previously cleared CoCr heads, zirconia heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.