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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® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.

EcoFit® Vit E Acetabular System (portfolio expansion) – K180263
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® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.

MUTARS® Proximal Femur Replacement System – K181778
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 to for uncemented use in total hip arthroplasty 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.

AGILON® XO Shoulder Replacement System – K191433
The AGILON® XO Shoulder Replacement System is indicated for use for cementless or cemented 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® 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 be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse 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 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

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 provision of prostheses is generally indicated only in patients whose skeleton is fully grown.
ic-Bipolar Head System – K191569
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.

MUTARS® Cemented Femoral Stem (portfolio expansion) – K200045
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 and 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.

Use of the prosthesis is generally only indicated in skeletally mature patients.

ACS® LD Uni FB Knee System – K203341
The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

This device is single-use implant intended for implantation with bone cement.
EcoFit® Hip System (portfolio expansion) – K203420
Acetabular Inserts
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 to 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.

Femoral Stems
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® Hip Stem is intended for uncemented, press-fit fixation.

The 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 Systemor 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.

implaFit® hip stems – K210678
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 intended for uncemented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation.
AGILON XO Shoulder System (portfolio expansion) – K222482
The AGILON® XO Shoulder Replacement System is indicated for use for cementless 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 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.
BethaLoc® stem cementless HA – K223103
The EcoFit®, implaFit® and BethaLoc® 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 EcoFit®, implaFit® and BethaLoc® 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 EcoFit® hip stems, the implaFit® hip stems cementless and the BethaLoc® hip stems are intended for uncemented, press-fit fixation.
The implaFit® hip stems cemented are intended for cemented fixation.
The 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 BethaLoc® hip stems and 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.

Actinia® hip stems – K232371
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 un-manageable 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.

AGILON® XO Shoulder Replacement System (portfolio expansion) – K231657
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 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 glenoids cementless are intended for cementless use with the addition of screws for fixation.

MUTARS® femoral stem cemented 160 mm and 200 mm (portfolio expansion) – K240391
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 and 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.

Use of this prosthesis is generally only indicated in skeletally mature patients.

EcoFit® short stem cementless cpTi (portfolio expansion) – K240834
The EcoFit® 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 EcoFit® hip stems are intended for uncemented, press-fit fixation.

The EcoFit® 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.

ACS® LD FB Knee System – K234044
General total knee arthroplasty indications include:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
Post-traumatic loss of knee joint configuration and function
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament.

The ACS® LD FB Knee System is intended for cemented use, single use only.

The ACS® LD FB Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

AGILON® XO Shoulder Replacement System (portfolio expansion) – K241944

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 avascularnecrosis,
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 and 4-fragmentfractures (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 assalvage procedure
From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplastyas salvage procedure
From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total ShoulderArthroplasty
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 glenoid cementless is intended for cementless use with the addition of screws for fixation.

Device Description

This Traditional Premarket Notification is for an update to the packaging system of multiple previously 510(k) cleared devices. These devices include hip systems, shoulder systems, and knee systems. There have been no changes to these devices, aside from the packaging system, since the time of the clearance. The new packaging system will be introduced for all products supplied sterile.

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