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Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. When used with MDM® Liners Treatment of nonumion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Dislocation risks When used with Constrained Liner The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. The Trident® II Acetabular Shells are indicated for cementless use only.

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and dome hole plugs are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident® Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments. The purpose of this Special 510(k) is to add an additional dome hole plug option for use with the Trident® II Acetabular System.

The Trident® II Acetabular System is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty. Indications for Use: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. When used with MDM Liners: • Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. - Dislocation risks When used with Constrained Liners: • The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. The Trident II Acetabular Shells are indicated for cementless use only.

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and Hex Dome Hole Plug are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular System is an extension of the Trident System product line and features the same locking mechanism as the current Trident® and Trident® II Tritanium® product lines. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments. The Trident® II Tritanium® implant consists of a unique configuration of both solid and porous sections that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology. Tritanium® is a novel highly porous titanium material designed for biological fixation. The Trident® II PSL® Clusterhole HA and Trident® II Clusterhole HA Acetabular Shells feature hydroxylapatite coating over a Commercially Pure Titanium plasma sprayed surface for cementless fixation.

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. When used with MDM Liners: Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Dislocation risks When used with Constrained Liner: The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. The Trident® II Tritanium Acetabular Shells are indicated for cementless use only.

The Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screws are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Tritanium® Acetabular Shell is an extension of the Trident System product line and features the same locking mechanism as the current Trident® Tritanium® product line. The Trident® II Tritanium® Acetabular Shell is intended to be used with existing Trident® polyethylene inserts, MDM® liners and existing surgical instruments. The subject device is manufactured from Ti-6Al-4V ELI alloy. The implant consists of a unique configuration of both solid and porous structures that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology. There are three designs of Trident® II Tritanium® Acetabular Shells: Solidback (sizes 42A-66H) Clusterhole (sizes 42A-66H) Multihole (sizes 42A-72J) The new compatible 6.5mm Low Profile Hex Screws feature a hex geometry and are manufactured from wrought Ti-6Al-4V ELI. The new screws range in lengths from 15-80mm.