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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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: - · Revision procedures where other treatments or devices have failed; The porous coated femoral component may be used cemented (biological fixation). The porous coated tibial baseplate is to be used uncemented (biological fixation). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only. The Apex Knee™ Modular Tibial Augments are intended to the Tibia baseplate and cemented to the prepared tibia.

The proposed devices are intended to be used for primary and revision total knee replacement. The Pegged Tibial Baseplates offer additional torsional stability by adding pegs to the posterior end of the device. The material of the proposed Pegged Tibial Baseplates are Cobalt Chrome, CoCr (ASTM F75). The ECiMa tibial inserts are machined from compression molded highly crosslinked polyethylene with Vitamin E (VE-XLPE) and attaches to the cobalt chrome tibial baseplate via dovetails and a retaining

The OMNI ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat 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 OMNI ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

The proposed devices are intended to be used for primary and revision total hip replacement. The OMNI ARC Anteverted Neck Hip Stem offers anteverted neck options (left and right orientations) to the monoblock stem system to meet the variety of patient anatomies expected in Total Hip Arthroplasty. This design is similar to the ARC Monoblock stem designs currently marketed. The material of the proposed OMNI ARC Anteverted Neck Hip Stems are Ti-6Al-4V E.L.I (ASTM F136)

The OMNI Anseris Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat 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 OMNI Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

The OMNI Anseris Stem is a "fit and fill" femoral stem with a tapered conical design and is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System.

The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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; Revision procedures where other treatments or devices have failed; The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to be bolted to the femoral component and cemented to the prepared femur.

The proposed devices are intended to be used for primary and revision total knee replacement. The Revision Tibia Baseplates offer enhanced torsional stability by adding keels to the posterior end of the device. This design is similar to keeled stem designs currently marketed. The retaining bolt modifications offer additional bolt sizes that allow the cleared tibial inserts to lock into the proposed longer Revision tibial Baseplate. The material of the proposed Revision Tibial Baseplate is Cobalt Chrome, CoCr (ASTM F75). The material if the proposed retaining bolts is Ti-6Al-4V E.L.I (ASTM F136)

The OMNI Skirted Heads are intended for use in combination with the NOVAE® Dual Mobility Acetabular Cup and are indicated for total hip replacement, which includes: • Osteoarthritis • Femoral neck fracture • Dislocation risk • Osteonecrosis of the femoral head • Revision procedures where other treatments or devices have failed and if bone reconstruction so permits. SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.

The OMNI Skirted Heads are intended to be used in the primary/revision total hip replacement procedures in combination with the SERF Dual Mobility Acetabular Cup. These femoral heads are manufactured from cobalt chromium (CoCr) and are designed to be used with the SERF Dual Mobility Acetabular cup. These heads offer a skirted feature and when used with the Dual Mobility cups, the skirt extends over the exposed femoral taper and reduces the contact between the SERF polyethylene liner and machined surface of the K1 stem trunnion. SERF obtained clearance to use the OMNI K1 stem with its Dual Mobility NOVAE Acetabular Cup under K111572. In this submission, OMNI proposes two sizes for these skirted heads – 28mm+7 and 22mm+3.5 diameter and neck length respectively.

The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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: - · Revision procedures where other treatments or devices have failed; The porous coated femoral component may be used cemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to the femoral component and cemented to the prepared femur.

The proposed devices are intended to be used for primary and revision total knee replacement. The fluted femoral stems and the keeled femoral stems are slight modifications of the existing designs. The femoral stems offer enhanced press-fit implantation and torsional stability by adding longitudinal raised ribs similar to most stems designs currently marketed. The notched 10mm posterior femoral augment has been created to increase the product offerings when using posterior augments. The new notched augment will allow a 10mm distal augment and 10mm posterior augment to be used together. The femoral Locking Bolt functions similarly to the tibial locking bolt. It was designed for femoral use for enhanced fixation of the stem to the femur. The current tibial peg offers additional torsional stability when added to the modular tibial baseplate. The proposed revision tibial Peg is a slight modification of that existing tibial peg and is improved in size and torque strength. The Augment Peg Bolt is similar to the tibial peg and can be used to add additional torsional stability to the modular tibia baseplate when augments are used. The material of each new component is titanium alloy Ti-6Al-4V E.L.I (ASTM F136)

The OMNI ARC Monoblock Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Coball Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate: - . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; - . Rheumatoid arthritis; - Correction of functional deformity; . - Congenital dislocation; . - י Revision procedures where other treatments or devices have failed; - . Femoral neck and trochanteric fractures of the proximal femur. The OMNI ARC Monoblock Hip Stem is also intended for use in hemiathroplasty when used with the Apex Bipolar Head. The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: - · Femoral neck and trochanteric fractures of the proximal femur; - · Osteonecrosis of the femoral head; - · Revision procedures where other treatments or devices for these indications have failed.

The OMNI ARC Monoblock Hip Stem consists of a curved, rectangular tapered stem that combines the neck and stem into a single piece design. The OMNI ARC Monoblock Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface Acetabular System. The Apex Interface Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat 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 OMNI ARC™ Monoblock Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: Femoral neck and trochanteric fractures of the proximal femur; Osteonecrosis of the femoral head; Revision procedures where other treatments or devices for these indications have failed.

The Apex ARC™ Hip Stem is intended for use as the femoral component of a primary, or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobait Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat 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 Hip System ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiathroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: • Femoral neck and trochanteric fractures of the proximal femur; • Osteonecrosis of the femoral head; • Revision procedures where other treatments or devices for these indications have failed.

The Apex ARC Hip Stem consists of a curved, rectangular tapered stem with a distal slot, and modular necks that connect to the tapered hole in the stem. The larger size stems have a lateral feature referred to as a lateral t-flange. The T-flange is reduced in size on the smaller stem sizes (size 1 and 2), and further reduced to no t-flange on the smallest (subject) size 0 stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. The Apex ARC Hip Stem is available with and without HA coating. The necks are compatible with the Cobalt Chromium and Ceramic modular heads, and may be used with head diameters and offsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunction with the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty.

The Apex All Poly Tibia is intended for use as part of a primary or revision total knee replacement. 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; - Revision procedures where other treatments or devices have failed. The Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.

The Apex All Poly Tibia is used as part of a primary or revision cemented total knee implant using established total knee arthroplasty procedures. The All Poly Tibia is intended for use with bone cement, single use implantation and for use only with the Apex Knee™ System Femoral and Patella components. The device is machined from compression molded Ultra High Molecular Weight Polyethylene (UHMWPE per ASTM F648). This device is a semi-constrained monoblock tibia and designed for posterior cruciate substitution.

The Apex ARC™ Hip Stem is intended for use as the femoral component of a primary, or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat 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 Hip System ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: - · Femoral neck and trochanteric fractures of the proximal femur; - · Osteonecrosis of the femoral head; - Revision procedures where other treatments or devices for these indications have failed.

The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The height of the anterior and posterior lateral protrusions (Lateral T-Flange) was reduced on Size 1 and 2 ARC Hip Stems. Three new neck sizes are offered, Long Neutral, Long 8 ° Varus/Valgus and Anteverted. The necks are compatible with the Cobalt Chromium and Ceramic modular heads, and may be used with head diameters and offsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunction with the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty.