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510(k) Data Aggregation
(336 days)
• Reverse Shoulder Prosthesis
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The Reverse Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
• Anatomic Shoulder Prosthesis
The Medacta Anatomic Shoulder Prosthesis is intended for use as a hemi or total shoulder replacement for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The humeral stems are intended for cemented or cementless use.
The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use.
• Reverse Shoulder Prosthesis – monobloc stem
The reverse shoulder prosthesis using the standard monobloc stem is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The reverse shoulder prosthesis using the short monobloc stem is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The short monobloc stem is intended for cementless use only.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
• Anatomic Shoulder Prosthesis – monobloc stem
The anatomic shoulder prosthesis using the standard monobloc stem is intended for use as a hemi or total shoulder replacement. It is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.
The anatomic shoulder prosthesis using the short monobloc stem is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The short monobloc stem is intended for cementless use only.
The MSS – Monobloc stem is a Medacta Shoulder System line extension including the following implantable, individually packed, sterile and single-use devices:
- Monobloc stem, 11 sizes available in both standard and short versions. Short version has been designed, as the standard version, made of Ti6Al7Nb with Ti+HA coating, but also made from Ti6Al4V powder through an additive manufacturing process;
- Monobloc stem spacer small and large;
- Monobloc stem double eccenter small and large;
- Monobloc stem spacer/double eccenter screw;
- Distal screws with lengths from 18 to 36 in 2mm steps;
- Humeral reverse liners small and large available both in UHMWPE highcross and UHMWPE + vitamin E;
- Humeral reverse metaphysis small concentric and eccentric.
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