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Noninflammatory degenerative (oint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory (out disease (IJD), e.g., rheumatoid arthritis. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty.

The Subject CoCr Heads are intended to be used as a modular head component for articulation in total hip arthroplasty. A system consisting of a femoral stem, a ball head and a cup or a shell with an insert is used for replacement of the proximal femur in total hip arthroplasty. The articulation is comprised of a modular femoral head and a corresponding cup or acetabular insert. CoCr Heads are to be used in combination with polyethylene cups or inserts. It is also possible to use CoCr Heads in revision cases (unless subsequent to a broken ceramic component) where the stem remains in place. The Subject CoCr Heads have a head diameter of 38 mm and are provided with 5 different neck lengths (from -8 to +8) to allow an individual adaptation of leg length and offset. A 12/14 taper, incorporated in the design of the head, interlocks with the femoral stem. The CoCr Heads are made from Protasul®-20 (CoCrMo alloy).

The AFFIXUS® Natural Nail® System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preiniured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. The AFFIXUS Humeral Nails are indicated for use in a variety of fractures, such as: - · Proximal fractures (proximal short and long nails only) - · Diaphyseal fractures (proximal long, antegrade/retrograde nails) - · Open and closed fractures - · Comminuted fractures - · Nonunions and malunions - · Pathologic fractures

The Affixus Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. Nails and nail caps are made from Tivanium® Ti-6Al-4V alloy. Screws are also made from Tivanium alloy. Package labels indicate the material of each component. Selected components of the Affixus Natural Nail System are colour coded to aid in identifying which components should be used together. Refer to the colour coding chart and/or surgical technique for more detailed instructions on the use of Affixus Natural Nail System components.

Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems: · Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - · Failed previous surgery where pain, deformity, or dysfunction persists. · Revision of previously failed hip arthroplasty The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of: - · Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases - · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, or total hip replacement (THR) - · Acute traumatic fracture of the femoral head or neck - · Avascular necrosis of the femoral head. - · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. - · Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists. - · Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. - · Acute traumatic fracture of the femoral head or neck. - · Avascular necrosis of the femoral head. The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following: · Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. · Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity. · Patients with acute femoral neck fractures. The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following: · Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. - · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. - · Patients suffering from disability due to previous fusion. - · Patients with previously failed endoprostheses and/or total hip components in the operative extremity. - · Patients with acute neck fractures. - This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions: - Noninflammatory degenerative joint disease (NID), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis. - · Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists. - · Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure. • Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. · Failed previous surgery where pain, deformity, or dysfunction persists. · Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. · Revision of previously failed hip arthroplasty

Zimmer Hip Joint Replacement Prostheses are hip replacement system components. A femoral stem component is used in conjunction with a femoral head component for replacement of the proximal femur in total hip arthroplasty. Femoral stems are available in different designs, materials, sizes, neck lengths and taper sizes. A taper is incorporated in the design of the stem to interlock it with the femoral head. Femoral head components are available in a variety of sizes and neck lengths for reconstruction of the natural head center of the femur. The purpose of this submission is the addition of MR conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging, or sterilization.

Hemi- or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System The Anatomical Shoulder Humeral Stems and Domelock System are indicated for: • Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate. • Avascular necrosis. • Conditions consequent to earlier operations. • Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure). The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System • The Anatomical Shoulder Reverse System and the ASHCOM Shoulder system are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. • The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation. Fracture Application of the Anatomical Shoulder Fracture System The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi- and fracture shoulder arthroplasty in treatment of the following: • Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment. • Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment. • Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment. • Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus. • Posttraumatic necrosis of the humeral head. • Posttraumatic arthrosis after humeral head fracture. The Humeral Fracture Stems are intended for either cemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented are intended for cemented use only. Anatomical Shoulder Combined System Advanced destruction of the shoulder joint resulting from: • Omarthrosis • Rheumatoid arthritis • Post-traumatic arthritis • Avascular necrosis of the humeral head • Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater) • Conditions following earlier operations The Anatomical Shoulder Combined System is intended for cemented or cementless use. When used with the following humeral stems the Anatomical System is intended for cemented use. • Anatomical Shoulder Standard Cemented Humeral Stem • Anatomical Shoulder Long Stem When used with the following humeral stem the Anatomical System is intended for cementless use: • Anatomical Shoulder Standard Uncemented Stem. When used with the following humeral stems the Anatomical System is intended for cemented or cementless use: • Anatomical Shoulder Fracture Stem. • Anatomical Shoulder Fracture Long Stem. When used with the following glenoids the Anatomical System is intended for cemented use: • Bigliani/Flatow Glenoid (pegged and keeled). • Trabecular Metal™ Glenoid.

The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision (Reverse Shoulder Arthroplasty), total or hemi- shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis. The proposed Anatomical Shoulder System is comprised of the following families of products: Anatomical Shoulder Humeral Stems (Cemented, Uncemented) Anatomical Shoulder Reverse System (Cups, PE-inlays, Glenoid Fixation, Screws, Glenospheres) Anatomical Shoulder Fracture System (Stems, Heads) Anatomical Shoulder Combined system (Bigliani / Flatow® Adaptors) Anaverse™ Anatomical Shoulder Pegged Glenoid Anatomical Shoulder Domelock® System (Heads, Dome Centric, T-Domes) Anatomical Shoulder ASHCOM® Shoulder System (ASHCOM Shoulder AC-Connector)

Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems: • Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. · Failed previous surgery where pain, deformity, or dysfunction persists. • Revision of previously failed hip arthroplasty

The Alloclassic® Zweymüller® SL Femoral Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. The general design of the Alloclassic Zweymüller SL Femoral Stem comprises a slim neck and a short taper. Alloclassic Zweymüller SL Femoral Stems are available in 14 sizes and 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 Alloclassic Zweymüller SL Femoral Stem is manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM 1295-16). The entire stem below the neck of the hip stem is grit basted to provide enhanced bone/prosthesis interface. The design of Alloclassic® Zweymüller® SL Offset Femoral Stem is very similar to the previously cleared Alloclassic Zweymüller SL Femoral Stems (K962101, K030373), and identical to the previously cleared Alloclassic Zweymüller SL Offset Femoral Stem (K033664). Similar to the Alloclassic Zweymüller SL Femoral Stem, the Alloclassic Zweymüller SL Offset Femoral Stem is a conically shaped straight stem with a rectangular cross section for rotational stability. The entire stem below the neck of the hip stem is grit blasted to provide enhanced bone/prosthesis interface. The stem is available in 14 sizes and is manufactured from the wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM 1295-16). In contrast to the Alloclassic Zweymüller SL Femoral Stem, the Alloclassic Zweymüller SL Offset Femoral Stem provides an additional 6.25 mm of offset (per size) and has a CCD/neck angle of 121° (vs 131° for SL stem). Overall the Alloclassic Zweymüller SL Offset Femoral Stem design provides a higher offset sometimes needed for correcting insufficient soft tissue balancing, restoration of leg length, and sufficient joint stability following total hip arthroplasty.

Avenir® Müller Stem is intended for: Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.Acute traumatic fracture of the femoral head or neck.Avascular necrosis of the femoral head. Avenir® Müller Stems are for cementless use only. The Avenir® Cemented Hip Stem is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of: Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseasesFailed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)Acute traumatic fracture of the femoral head or neckAvascular necrosis of the femoral head.

The Avenir® Müller Stem is a titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit and the stem features proximal ribs on the anterior and posterior surfaces which are designed to increase stability. Except for the polished neck area, the surface of the stem is coated with Ti-6Al-4V titanium alloy plasma spray and oversprayed by a hydroxyapatite coating. The stem is available as both a lateralized and standard version. The Avenir® Cemented Hip Stem is a stainless steel alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit. The stem is highly polished and available as both a lateralized and standard version.

This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions: • Noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis. • Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists. • Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure. This stem is for uncemented use only.

The Fitmore® Hip Stem is a modular femoral stem intended for total or hemi-hip arthroplasty. The component is an uncemented stem which is coated proximally with Titanium Vacuum Plasma Spray and rough-blasted distally for primary stability. The stem design is curved and features a trapezoidal cross-section. The 12/14 femoral stem is available in multiple sizes, consisting of three stem families. The different family designs were developed in order to meet various patients' anatomic needs. As the anatomic offset varies considerably between individuals, the Fitmore® Hip Stem offers a wide range of offset options. Each family is designed with a CCD angle of 140°, 137°, 129° and 127°.

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Cephalomedullary nails include: - Compound and simple shaft fractures - Proximal, metaphyseal and distal shaft fractures - Segmental fractures - Comminuted fractures - Fractures involving osteopenic and osteoporotic bone - Pathological fractures - Fractures with bone loss - Pseudoarthrosis, non-union, mal-union and delayed union - Periprosthetic fractures - Surgically created defects such as osteotomies - Intertrochanteric and subtrochanteric fractures

The Zimmer® Natural Nail® System Cephalomedullary Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. A set screw (with a polyethylene peg) allows guided rotational stability of the lag screw. Nails, nail caps and screws are made from Tivanium Ti-6Al-4V Alloy. Set screws are made from Tivanium Ti-6Al-4V Alloy and Polyethylene (PE). Selected components of the Zimmer Natural Nail System are color coded to aid in identifying which components should be used together. The package label for each of the nails indicates which screw sizes should be used with that nail. A screw case that holds unused screws intended for resterilization is available and contains designated sections for each screw size. Each section contains the color name that matches the color/color name on the label of the appropriate screw size for that section. Refer to the color coding chart and/or surgical technique for more detailed instructions on the use of Zimmer Natural Nail System components.

The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following: • Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. • Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. • Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity. • Patients with acute femoral neck fractures. The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following: • Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. • Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. • Patients suffering from disability due to previous fusion. • Patients with previously failed endoprostheses and/or total hip components in the operative extremity. • Patients with acute neck fractures.

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty. The BIOLOX OPTION Ceramic Femoral Head System consist of a ceramic head fabricated from an alumina matrix composite available in diameters of 28, 32, 36, and 40 mm and a titanium adapter for the femoral stem cone with a range of offsets to accommodate various patient anatomies. The system serves as an alternative to both metal and alumina ceramic femoral heads and is for use in both primary and revision total hip arthroplasty.

The NCB Plating System is indicated for temporary internal fixation of fractures and osteotomies of long bones.

The NCB Plating System is an extramedullary internal fixation plate system to be used for either distal femoral or proximal tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.