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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components - glenophere, baseplate, and fixation component (screw or post) . All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

The ARROW Off-Centred Humeral Insert is designed for the following indications: REVERSE PROSTHESIS (POROUS GLENOID IMPLANT) The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the porous glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

The ARROW Off-Centered Humeral Insert is used for reverse shoulder prosthesis, with implants of Arrow Reverse Shoulder System (K112193 and K150568), similar to the standard version. This is a modification of the standard ARROW reverse prosthesis (K122193), with the purpose of reducing lateralization of the prosthesis, increase the range of motion, and provide better adaptation for patient anatomy. The ARROW Off-Centered Humeral Insert is made up of four components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, polyethylene UHMWPE per ASTM F648/ISO 5834-1, and stainless steel 316L per ASTM F138/ISO 5832-1, identical to the previous ARROW Humeral Insert cleared in the 510(k) file ARROW Reverse Shoulder System (K112193). All components are provided sterile via gamma irradiation.

E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

e-Ortho Shoulder software is a web-based surgical planning software application. e-Ortho Shoulder provides a pre-surgical planning tool for surgeons that helps them understand their patient's anatomy prior to surgery. Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan. E-Ortho allows surgeons to work in three-dimensional (3D) visualization, implant visualization and positioning within the specific patient's bone model (scapula and humerus), using reliable landmarks. This allows surgeons to preoperatively select the needed implant and determine its desired position. The subject submission seeks to add humeral planning capabilities to the previously cleared FH E-Ortho Shoulder Software. Additional changes to the software have been made to improve functionality within the previously cleared intended use.

The prostheses from FH Industrie are designed for specific indications such as: SIMPLE HUMERAL PROSTHESIS - Humeral head necrosis without injury to the glenoid cavity. - Extensive humeral head cartilage damage without injury to the glenoid cavity - Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant. - Rheumatoid polyarthritis with thin rotator cuff. - Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°. TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS) - Centred glenohumeral osteoarthritis with functional rotator cuff - Rheumatoid polyarthritis with functional rotator cuff - Post-traumatic sequela, functional rotator cuff with glenoid injury. TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT) - Centred glenohumeral osteoarthritis - Rheumatoid polyarthritis - Post-traumatic sequela with glenoid injury - Revision for glenoid loosening - Glenoid bone loss, where bone graft is needed - A functional rotator cuff is necessary to use this device REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT) The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. For all types of prosthesis, the glenoid baseplate (metal-back or porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem) is intended for cementless use. At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

The ARROW Humeral Short Stem Humeral System is an extension of humeral stem range of the Arrow prosthesis. The short stem is composed of a metaphyseal part and a cylindrical diaphyseal part. Both components are offered in various sizes to accommodate patient anatomy. This modular stem helps for better adaptation to each patient's anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3. The metaphysis has fins to provide rotational stability; it has a pure titanium plasma spray coating per ASTM 1580.

Fracture of the proximal extremity of the humerus. Fracture of the diaphysis of the humerus.

The FH Industrie TELEGRAPH® EVOLUTION Humeral Nailing System includes short and long intramedullary cannulated humeral nails with right and left orientations, proximal screws and a washer. The nails, screws, and washer are intended for use in treatment of fracture of the proximal extremity of the humerus or fracture of the diaphysis of the humerus. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The nails that are the subject of this submission are cannulated.

E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

e-Ortho Shoulder software is a web-based surgical planning software application. e-Ortho Shoulder provides a pre-surgical planning tool for surgeons that helps them understand their patient's anatomy prior to surgery. Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan. E-Ortho allows surgeons to work in three-dimensional (3D) visualization, implant visualization and positioning within the specific patient's bone model (scapula and humerus), using reliable landmarks. This allows surgeons to preoperatively select the needed implant and determine its desired position.