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The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented and uncemented applications, as specified in the following table: | COMPONENT | USE | | |-------------------------|----------|------------| | | Cemented | Uncemented | | Cemented stems | X | | | Cementless Finned stems | | X | | Trauma Humeral Bodies | X | X | | Finned Humeral Bodies | X | X | | Humeral Heads | X | X | | Adaptor Tapers | X | X | | Cemented Glenoids | X | | Total or hemi-shoulder replacement is indicated for patients suffering from disability due to: - · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - · Inflammatory degenerative joint disease such as rheumatoid arthritis; - · Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods

The SMR Shoulder System consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid components are offered for hemi or total shoulder joint arthroplasty, in primary trauma surgery. Humeral components are provided in different designs and are intended for cementless use while glenoid components are intended for cemented use only. Two designs of humeral stems are available: the first one (object of this submission) is intended for uncemented use while the second one (submitted in 510(k): K100858) is intended for cemented use only. Two lengths of uncemented humeral stems are available: 60 and 80 mm. The 60 mm stems are characterized by an outline with a double conicity and they are finned to provide optimal proximal fixation. The stem is sand-blasted. The 80 mm stems are characterized by an outline with a triple conicity and are also finned to provide optimal fixation. The proximal part is sand-blasted while the distal part is polished. All stems are made from Ti6Al4V (ISO 5832-3, ASTM F1472). The stems are provided with a male Morse taper (identical to that described in K100858) to allow coupling with the humeral bodies. Humeral bodies are available in two designs. The first one (submitted in 510(k): K100858) is characterized by holes for humeral bone reconstruction as a consequence of trauma while the second one (object of this 510(k)) is finned to allow proximal press-fit fixation of the humeral system. Both designs of humeral bodies can be used in cemented (with cemented stems submitted in 510(k): K100858) and in uncemented applications (with uncemented stems submitted in this 510(k). Humeral bodies are made from Ti6Al4V (ISO 5832-3, ASTM F1472). They are coupled with the humeral stem via a female Morse-taper connection; a locking screw is provided to aid in initial mating of the stem / body assembly.. Cylindrical marks are designed at the base of this Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morse-taper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morse-taper and the axis of the stem gives the correct varus-valgus alignment to the joint. The device descriptions for the adaptor tapers, humeral heads and glenoid components submitted in K100858 are repeated here in italic typing for a better understanding of the complete system. Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V. They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and provide the required offset to the humeral head to achieve the correct tensioning to the soft tissues, optimizing joint stability. The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder arthroplasty. The surface is polished to aid in the reduction of wear. The glenoid components are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head, which allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation.

The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented applications. Total or hemi-shoulder replacement is indicated for patients suffering from disability due to: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis: - Inflammatory degenerative joint disease such as rheumatoid arthritis; - Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods

The SMR Shoulder System consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid component. Components are offered for cemented use for hemi or total shoulder joint arthroplasty, in primary trauma surgery. Humeral stems are designed for cemented use and are characterized by an outline with a triple conicity to provide optimal fixation and fit independent of canal morphology. The stems are made from Ti6Al4V (ISO 5832-3, ASTM F1472). The surface in contact with cement is polished to reduce shear stresses on the cement mantle and avoid abrasion resulting from micromovements at the stem-cement interface. The distal part of the stems is characterized by a cylindrical cross-section while the proximal part is fluted to prevent rotation of the component relative to bone. The stems are provided with a male Morse taper in the proximal part for coupling with the humeral body. Humeral bodies are made from Ti6Al4V and are coupled with the humeral stem via a female Morse-taper connection; a locking screw is provided to aid in initial mating of the stem / body assembly. Cylindrical marks are designed at the base of the Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morsetaper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morsetaper and the axis of the stem gives the correct varus-valgus alignment to the joint. A system of holes on the external surface allows anatomical attachment of tuberosities using sutures or wires in trauma applications. Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V. They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and provide the required offset to the humeral head to achieve the correct tensioning to the soft tissues, optimizing joint stability. The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder joint arthroplasty. The surface is polished to aid in the reduction of wear. The glenoid components are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head, which allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation.