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The Alpha™ Metasul® Acetabular Insert is intended for use in total hip arthroplasty for treatment of the following: - patient conditions of noninflammatory degenerative joint disease (NIDD), e.g., rheumatoid arthritis; - Those patients with failed previous surgery where pain, deformity, or dysfunction persists; - Revision of previously failed hip arthroplasty.

The Alpha Metasul Acetabular Insert (28mm and 32mm) is a hemispherically shaped design, composed of an outer component manufactured from ultra-high molecular weight polyethylene (UHMWPE) thermo-mechanically bonded to a wrought hot-forged CoCr alloy metallic inlay (in compliance with ISO 5832-12 and ASTM F1537). The Alpha Metasul Acetabular Insert is designed for use only with a Metasul femoral head. The Alpha Metasul Acetabular Insert is a metal-on-metal component, metal surfaces. The Alpha Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes 52mm to 68mm (in 2mm increments). In turn, the proposed Alpha Metasul 32mm Acetabular Inserts are designed to mate with Allofit™ Acetabular Shells, sizes 48mm to 68mm (in 2mm increments). Both insert sizes mate the same basic design as the previously cleared Alpha Metasul 28mm Acetabular Insert and share many features with the Ringloc® Acetabular Liner and M2a -Taper Acetabular System. The Alpha Metasul Insert has what is commonly referred to as a "poly-sandwich" design. The bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and themo-mechanically bonded into the proven polyethylene liner, which is then locked into the Allofit acetabular shell via a blocked in snap mechanism. On the hooded inserts, the face of this polyethylene liner incorporates an overhang of polyethylene extending beyond the midpoint of the metallic inlay to help prevent subluxation and instability.

The 32mm Epsilon Metasul Acetabular Insert and Metasul Femoral Head are intended for use in total hip arthroplasty for treatment of the following: - patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., . avascular necrosis, osteoarthritis, and inflammatory joint disease (JJD), e.g., rheumatoid arthritis: - those patients with failed previous surgery where pain, deformity, or dysfunction . persists: - . revision of previously failed hip arthroplasty.

The Epsilon Metasul 32mm Acetabular Insert is a hemispherically shaped design, composed of an outer component manufactured from polyethylene (UHMWPE) (in compliance with ASTM F648) which is thermo-mechanically bonded to a wrought hotforged CoCr alloy metallic inlay (in compliance with ISO 5832-12). The Epsilon Metasul Acetabular Insert is designed for use only with a Metasul femoral head component, as a metal-on-metal system. The body's natural synovial fluid lubricates the metal surfaces. The Epsilon Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes designed to mate with Converge® Acetabular Shells, sizes 53mm to 81mm (in 2mm increments). The Epsilon Metasul 32mm Insert has what is commonly referred to as a "polysandwich" design. The inner diameter, which forms the bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and thermomechanically bonded into the polyethylene liner, which is then locked into the Converge acetabular shell via the proven snap mechanism. On the hooded inserts, the face of the polyethylene outer diameter incorporates a 20° overhang of polyethylene extending superiorly from the midpoint of the insert face. This hood feature is designed to provide additional resistance to subluxation and instability. The 32mm Metasul® Modular Femoral Head is manufactured from Protasul-21WF (wrought forged CoCrMo, in compliance with ISO 5832-12). The design incorporates a 12/14 Morse-type female taper and a beveled face that allows for easier reduction of the hip intraoperatively. This femoral head component is offered in both a standard and an eccentric version, and is designed specifically to articulate with Centerpulse Orthopedics acetabular inserts having a Metasul® Inlav.

The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures.

The Durasul Bipolar consists of a polyethylene insert/liner and an outer CoCr shell. In vivo, the CoCr shell articulates directly with well-preserved articular cartilage while the Durasul insert articulates directly with a 22 or 26mm femoral head. The Durasul Bipolar components are available in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a hip hemi-arthroplasty.

The Natural-Knee II Unicompartmental Knee is intended for use in: - Unicompartmental noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and arthritis secondary to a variety of diseases and anomalies; - Passively correctable valgus-varus deformity and moderate flexion contracture; - Those patients with failed previous surgery where pain, deformity or dysfunction persists. The N-K II Unicompartmental All-Poly Tibia is intended to be used only with bone cement. The modular metal/polymer N-K II Unicompartmental Tibia and Femur are intended for use with or without bone cement.

The Natural-Knee II Unicompartmental Knee System is a conservative, cost-effective alternative to total knee replacement for patients with osteoarthritis primarily confined to one compartment. The N-K II Unicompartmental Knee System is intended for resurfacing of one side of the knee joint. The N-K II Unicompartmental Modular Metal-backed Tibia is similar to the previously cleared N-K II Unicompartmental Tibia (K955778). The wrought titanium alloy tibial baseplate is a symmetrically designed component, eliminating the need for left/right orientations. The baseplate features three smooth pegs on the underside which aid in positioning and rotational stability. A smooth surface finish is provided on the inner surface of the tibial tray to minimize the potential for polyethylene wear. A screw hole is placed in the center of the baseplate for optional screw fixation. The baseplate is available in either a porous or non-porous version. The all-poly tibia is designed with a single keel to position the component on the tibia and increase stability. Cement grooves on both the medial and lateral side of the keel increase the anchoring effect of the keel, while a dovetail cement channel around the perimeter of the distal surface, along with a T-pattern dovetail cement channel, act to resist movement in all directions. It is to be used only with bone cement for application directly onto the patient's resected proximal tibia. The metal-backed and the all-poly tibias are both available in 6 sizes (1-6). The modular metal-backed tibia will be offered in 3 thicknesses (9, 11, and 13 mm). The insert thickness reflects the total amount of bone to be resected. The all-poly insert will be available in 4 thicknesses (7, 9, 11, and 13mm), in which the thickness is measured at the thinnest point from the distal to the proximal surface of the component. The design of the femoral component of the proposed N-K II Unicompartmental Knee System will not change. This premarket notification only seeks to obtain clearance for the addition of cementless use of the previously cleared porous-coated femur (K955778).

The Alloclassic SL Offset Femoral Stem is intended for prosthetic replacement without bone cement in treatment of the following: - patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - those patients with failed previous surgery where pain, deformity, or dysfunction persists. . - revision of a previously failed hip arthroplasty. . - patients who require a total hip replacement. .

The Alloclassic Zweymüller SL Offset Femoral Stem is very similar to the previously cleared Alloclassic Zweymüller SL Femoral Stem in that it is: - a conically shaped straight stem with a rectangular cross section (for rotational stability). 1. - the same design, distal to the line of resection. 2. - manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11/ASTM 3. F1295). - grit blasted, below the neck, to enhance the bone-prosthesis interface. 4. In contrast, this stem provides an additional 6.25mm of offset (per size) and has a CCD/neck angle of 121° (vs. 131° for SL stem). Overall, this new design provides a higher offset sometimes needed for: - 1. correcting insufficient soft tissue balancing, - 2. restoration of leg length, and - sufficient joint stability following total hip arthroplasty. 3.

The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following: - Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - . Those patients with failed previous surgery where pain, deformity, or dysfunction persists. - . Revision of previously failed hip arthroplasty.

The Converge RETi-Lock Multi-Hole Reinforcement Cup is a hemispherical acetabular reinforcement shell made of titanium alloy. It is designed to expand the surgeon's options for treatment in cases when acetabular bone stock is deficient. This device also has a fixation plate designed to match the contour of the ilium of the acetabulum and a hook designed to attach to the obturator foramen. Numerous screw holes in the cup and along the plate help to ensure fixation in good bone stock.

The Epsilon™ Durasul® Constrained Acetabular Liner is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.

This device consists of two components: a liner and a ring, which will be assembled and attached to one of the corresponding Centerpulse Orthopedics Inc. acetabular shells. The liner mates with previously-cleared Centerpulse Orthopedics Inc. acetabular shell components via a snap lock mechanism. The metallic reinforcing ring provides added femoral head constraint once assembled. The fixation method of the acetabular components is porous cementless with supplemental screws, and the fixation method of the femoral components is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component. At the time of surgery, the constrained liner and ring will be assembled to the corresponding acetabular shell and femoral head.

The Wagner Cone Prosthesis is intended for prosthetic replacement of the proximal portion of the femur in total hip arthroplasty. This device is intended for cementless application where primary fixation occurs predominantly in the distal region. Specific diagnostic indications for use of the Wagner Cone Prosthesis are: - patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis; - those patients with failed previous surgery where pain, deformity, or dysfunction persists; - revision of previously failed hip arthroplasty.

This stem is a titanium-aluminum-niobium alloy conical configuration with a taper. The design features a circular cross-section with eight equally spaced conical longitudinal flutes down the long axis of the stem for rotational stability. The stem's core diameter tapers gradually from the proximal end to the distal end.

The tibial spacer is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following: - Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); e.g., avascular . necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g., rheumatoid arthritis; - Correctable valgus-varus deformity and moderate flexion contracture. - . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.

These Tibial Spacers are optional components designed to mate with the previously-cleared Natural-Knee II Cemented Modular Tibial Baseplate. Like the Tibial Baseplate, the Tibial Spacers are manufactured from cobalt chrome alloy. The tibial spacers are available in seven sizes (00 through 5) and in two thickness levels. They are available in both medial and lateral and both left and right configurations to match the radial contour of the baseplates.

The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is intended for prosthetic replacement without bone cement in treatment of the following: - patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - those patients with failed previous surgery where pain, deformity, or dysfunction persists. . - revision of a previously failed hip arthroplasty. ● - patients who requires a total hip replacement. .

The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. Distally the SLL stem is up to 20% longer than the same size SL stem, while maintaining the same conical features. This provides the surgeon with greater freedom of choice even in primary operations. A SLL stem of the same size as the pre-selected SL stem can be implanted to achieve primary stability in cases of unexpected poor bone quality. Distally the stem is anchored primarily by its edges; proximally the surfaces anchor against the bone cortex. The general design of the Alloclassic™ Zweymueller™ SL/SLL Femoral Stem with the slim neck and short taper remains unchanged as compared to the design of the previously cleared Zweymueller™ SL Femoral Stem. The modified design increases the patient's range of motion by up to 12° following a total hip replacement. The risk of impingement and ultimately the risk of dislocation are reduced following a total hip replacement. The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM F1295-92). The entire stem below the neck of the hip stem is grit blasted to provide enhanced bone/prosthesis interface.