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The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: - · Non- inflammatory deqenerative joint disease including osteoarthritis and avascular necrosis, - · Post-traumatic osteoarthritis. - · Fractures, - · Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: - · Multi-fragmental comminuted fractures of the humeral head, - · 3- and 4-Fragment-fractures of the proximal humerus, - · Head-splitting fractures, - · Dislocated head-splitting fractures, - · Humeral head depression with more than 40% of joint surface depressed, - · Interlocking chronic dislocation with deep HILL-SACHS lesion, - · Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening), - · Posttraumatic humeral head necrosis, - · Omarthrosis. AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: - · Rotator cuff tear arthropathy, - · Chronic trauma shoulder, - · Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows: - · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty - · From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty - · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure - From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The device is intended for adults. The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation. The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The qlenoid cementless is intended for cementless use with the addition of screws for fixation.

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with options depending upon the size and anatomical needs of each patient. The subject submission is for new cancellous screws for use in a total reverse shoulder replacement with the previously cleared K231657 components: - Humeral Head Components ● - Glenoid and Glenosphere Components ● - Humeral Stems and Stem Extension Pieces - Metaphyseal Components ● - Fixation and Cancellous Screws ● The subject line extension components are intended for use with previously cleared AGILON XO Shoulder System instruments. There are no changes to packaging, sterility, shelf life, or materials subject to this submission.

The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur System is intended for cemented use in total hip arthroplasty or hemiarthroplasty for the following indications: · Proximal femur replacement in oncology cases where radical resection and replacement of bone is required. · Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required. Use of this prosthesis is generally only indicated in skeletally mature patients.

The purpose of this Traditional 510(k) is to expand the MUTARS® Cemented Femoral Stems and MUTARS® Proximal Femur Replacement System with a line extension to the existing stems. The new stems are available with longer lengths (160 and 200mm).

The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: - · Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - · Post-traumatic osteoarthritis, - · Fractures, - · Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: - · Multifragmental comminuted fractures of the humeral head, - · 3- and 4-Fragment-fractures of the proximal humerus, - · Head-splitting fractures, - · Dislocated head-splitting fractures, - · Humeral head depression with more than 40% of joint surface depressed, - · Interlocking chronic dislocation with deep HILL-SACHS lesion, - Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening), - · Posttraumatic humeral head necrosis, - · Omarthrosis. AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: - · Rotator cuff tear arthropathy, - · Chronic trauma shoulder, - · Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary. In case of revision surgery, the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system, can be performed in revision cases as follows: - · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty - From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty - · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure - · From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The device is intended for adults. The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation. The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for fixation.

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined for use in a total (anatomic and reverse) or a hemi shoulder replacement: Hemi Shoulder: - Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap) - Humeral Stems (Cementless) Total Anatomic Shoulder: - Humeral Head Components (AGILON® XO Cap) - Glenoid Components (AGILON® PE-Glenoid, Cemented) - Humeral Stems (Cementless) Total Reverse Shoulder: - Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ● - Glenoid and Glenosphere Components (AGILON® XO Glenoid Baseplate and AGILON® ● Glenosphere) - Humeral Stems (Cementless) Metaphyseal components (including a new line extension 145°), stem extension pieces, and component connection fixation screws are intended to be used for hemi and total (anatomic and reverse) shoulder configurations. The subject system also includes device-specific reusable instruments for use with the subject implants, including an osteotomy guide, implant trials, and a humeral cutting block.

The Actinia® hip stems are intended to be used in total hip arthroplasty for the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - Rheumatoid arthritis; - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and - Revision of previously failed total hip arthroplasty. The Actinia® hip stems cementless are intended for uncemented, press-fit fixation. The Actinia® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head System for the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The Actinia® hip stems are femoral stems for total or hemi hip arthroplasty. The Actinia® hip stems include collared and collarless variants in standard and lateralized offset configurations. Additionally, the scope includes the coxa vara hip stem variant in a standard offset configuration. The Actinia® hip stems are monoblock, tapered straight stems made from titanium alloy with a coating of hydroxyapatite (HA). They are fixed by press-fitting. The Actinia® hip stems are to be used alongside other previously cleared components to make a complete prosthesis. Specifically, Actinia® hip stems are compatible with legally marketed heads used with the implantcast EcoFit® Hip System (K163577, K180263 and K191569) and the implantcast ic-Bipolar Head System (K191569).

The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: - Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - Post-traumatic osteoarthritis, - Fractures. - Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: - . Multifragmental comminuted fractures of the humeral head. - 3- and 4-Fragment-fractures of the proximal humerus, - Head-splitting fractures. - Dislocated head-splitting fractures, - . Humeral head depression with more than 40% of joint surface depressed, - Interlocking chronic dislocation with deep HILL-SACHS lesion, - . Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening), - Posttraumatic humeral head necrosis, - . Omarthrosis. AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty to treat a patient in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: - Rotator cuff tear arthropathy, - Chronic trauma shoulder, - Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement. In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows: - . From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty - From Hemi Shoulder Arthroplasty to Hemi CTA . Shoulder Arthroplasty - From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure - . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure - From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint. The device is intended for adults. The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.

The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared implantcast shoulder components to make a complete prosthesis.

The implaFit® hip stems are indicated for use in cases of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - Rheumatoid arthritis: - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and - Revision of previously failed total hip arthroplasty. The implaFit® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. The implaFit® hip stems cementless are intented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation.

The implaFit® hip stems are femoral stems for total or hemi hip arthroplasty. The implaFit® hip stems include cementless and cemented configurations (i.e., the implaFit® hip stems cementless and the implaFit® hip stems cemented). The implaFit® hip stems cementless are monoblock, collarless tapered straight stems made from titanium alloy with a partial coating of commercially pure titanium (cpTi). They are fixed by press-fitting. The implaFit® hip stems cemented are monoblock, collared, tapered straight stems made from cobalt chromium (CoCrMo). They are fixed using cement.

The EcoFit® Hip System is indicated for use as a total hip replacement in cases of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - Rheumatoid arthritis; - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and - Revision of previously failed total hip arthroplasty. The EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation. The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur System is intended for uncemented use in total hip arthroplasty or hemiarthroplasty for the following indications: - Proximal femur replacement in oncology cases where radical resection and replacement of bone is required. - Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required. The MUTARS® ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the EcoFit® Hip System and MUTARS® Proximal Femur Replacement System for the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The purpose of this Traditional 510(k) is to expand the existing EcoFit® Hip System portfolio with a line extension inclusive of additional acetabular inserts and cementless femoral stems.

The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur System is intended for cemented use in total hip arthroplasty or hemiarthroplasty for the following indications: - Proximal femur replacement in oncology cases where radical resection and replacement of bone is required. - Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required. Use of the prosthesis is generally only indicated in skeletally mature patients.

The purpose of this Traditional 510(k) is to expand the MUTARS® Proximal Femur System with a line extension to the existing cementless femoral stems. The new stems are intended for cemented applications.

The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System for the following indications: - Proximal femur replacement in oncology cases where radical resection and replacement of bone is required. - Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required. Use of this prosthesis is generally only indicated in skeletally mature patients. The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The ic-Bipolar Head System consists of a bipolar liner, retaining ring, and femoral head. The system is used for hip replacements in which the femur requires replacement but the acetabulum does not (i.e. hemi-arthroplasty) The ic-Bipolar Head System articulates directly with the natural (non-replaced) acetabulum on the outer side and with a femoral head on the inner side. The ic-Bipolar Head System is manufactured of CoCrMo and UHMWPE. The ic-Bipolar Head System is used in conjunction with the EcoFit® Hip System (K163577) and MUTARS® Proximal Femur Replacement System (K181778).