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The Indications for Use statements provided below are identical to those of each device in scope for the packaging system update:

EcoFit® Hip System – K163577
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.

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 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.
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.

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 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.

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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The implaFit® short 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 implaFit® short stems are intended for uncemented, press-fit fixation.

The implaFit® short 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 components introduced with this submission are intended to mate with other previously cleared components to make a complete prosthesis. The implaFit® short stem with collar cementless are offered in standard and lateralized offset versions. The components included in this submission consist of titanium alloy femoral hip stems, used in total and hemi hip arthroplasty and are intended for uncemented press fit application.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Nebula, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for 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.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

The Evolve AP and Evolve AP Vit-E Cups are manufactured of UHMWPE and GUR1020-E respectively and are all-polyethylene acetabular cups intended for cemented use. The Evolve Cups are compatible with Signature Orthopaedics Signature Femoral Heads. The Evolve AP Vit-E Constrained Cup is contraindicated for use with Signature Orthopaedics Origin-NS and Cemented TSI Femoral Stem.

The World Finned Cup is manufactured from Ti6Al4V and is a cementless acetabular cup featuring external fins to provide extra fixation and reduced rotation of the cup. The World Finned Cup is compatible with Signature Orthopaedics World Liners.

The World G-Zero Liner is manufactured from UHMWPE GUR1020-E and is a constrained acetabular liner for use in conjunction with the Signature Orthopaedics World Cups in total hip arthroplasty. The Oddball Femoral Head is manufactured from CoCr and is compatible with the World G-Zero liners to complete the constrained hip replacement. Both the G-Zero Constrained Liner and the Oddball Femoral Head are contraindicated for use with Signature Orthopaedics Origin-NS and Cemented TSI Femoral Stem.

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The G7® TM Acetabular System is intended for total hip arthroplasty in skeletally mature patients 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 by other techniques
• Revision procedures where other treatment or devices have failed

Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.

The G7® TM Acetabular System consists of a Trabecular Metal® coated acetabular shell, available in multi screw hole patterns, and Rim Fix™ screws.

The G7® TM Acetabular System is intended for use without bone cement in total hip arthroplasties. This system provides surgeons with multiple acetabular implant options to address a range of patient anatomies.

The G7® TM acetabular shells are made from Tivanium® (Ti-6Al-4V ELI Alloy) as per ASTM F136-13 with a porous Tantalum pad (Trabecular Metal®) per ASTM F560-22 that is diffusion bonded to the exterior of the shell.

The subject shells are designed to be compatible with the existing G7® acetabular liners and other accessories and instruments provided in the G7® Acetabular System platform.

The Rim Fix™ screws are self-tapping screws made from the same material of the shell, Tivanium® (Ti-6Al-4V Alloy) per ASTM F136-13. The subject screws are designed for use in the perimeter of the G7® TM acetabular shell rim to provide additional inferior fixation.

The subject implants are provided sterile and are for single-use only.

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The Mpact 3D Metal implants are designed for cementless use in total hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

• Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Mpact 3D Metal Implants Extension - DMLS Technology are a line extension to the Mpact 3D Metal Acetabular Shells and 3D Metal Augments (K171966, K202568) and to the Mpact Acetabular Systems Shells (K103721, K122641, K132879 and K230011) and are designed to be used with the Medacta Total Hip Prosthesis System. Specifically, the devices subject of this submission are:

• Acetabular shell size Ø44 Two-holes;
• Acetabular shell size Ø44 Multi-holes thin;
• Acetabular shells sizes from Ø42T to Ø58T of both Two-holes and Multi-holes Thin designs, allowing to be coupled with an increase size of liner.

The subject implants are intended to be used during Total Hip Arthroplasty to replace the acetabulum and they are provided individually packed, sterile and single-use. Similarly to the predicate devices, the subject acetabular shells are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder according to ASTM F2924-14.

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The Libertas® Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• Non-inflammatory degenerative joint diseases including osteoarthritis, post traumatic arthritis and avascular necrosis.
• Rheumatoid arthritis.
• Congenital hip dysplasia.
• Acute traumatic fracture of the femoral head or neck.
• Certain cases of Ankylosis.
• Dislocation of the hip.
• Correction of functional deformity.
• Revision of failed joint reconstruction or treatment.
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

Note:

• The Modular Shell and Uncemented Stem are intended for press-fit, uncemented use only.
• The Cemented stem is intended for cemented use only.

The Libertas® - Taper Short Uncemented Femoral Stem (the subject device) is a line extension of the Libertas Hip System comprising of hip stem components for uncemented use in total hip arthroplasty. The subject device components are forged out of Ti-6Al-4V compliant with ASTM F136 Standard Specification for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The subject device adds non-collared and collared hip stem components to the product line, for a more proximally filling uncemented stem option compatible with all standard surgical approaches for total hip arthroplasty, including modern muscle-sparing techniques.

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The indications for use for TaperSet™ Hip System are:

The TaperSet™ Hip System is designed for total hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System including the CS2™ Acetabular Cup System.

The indications for use are:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-union of proximal femoral neck fractures.
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The TaperSet™ hip stem is indicated for cementless use.

The Consensus acetabular cup components are intended for cemented or cementless use. The CS2 Ti plasma coated acetabular shell is intended for cementless use. The Consensus all-poly acetabular cup is intended for cemented use.

The intended use or indications for use of the TaperSet™ Hip System are similar to its original clearance K102399 except the removal of 'partial hip arthroplasty" as the DAA surgical technique is only applicable to the total hip system.

Shalby Advanced Technologies, Inc. has created the DAA surgical technique for its cleared TaperSet™ Hip System including hip implants – TaperSet Femoral Stems™ and CS2™ Acetabular Components as well as other compatible components.

There have been no changes made to the TaperSet™ Femoral Stems and CS2™ Acetabular Components or any other compatible components from their previous clearances in developing the DAA surgical technique.

The TaperSet™ Femoral Stems are available in sizes ranging from 5 to 24mm in standard and 7mm lateralized neck options. The TaperSet™ Femoral Stems with Reduced Distal Profile (RDP) are available in sizes ranging from 10.5 to 24mm in standard and 7mm lateralized neck options. The femoral stems are manufactured from wrought or forged titanium alloy (Ti-6Al-4V), except the 5 and 6mm femoral stems which are manufactured from forged titanium alloy (Ti-6Al-4V) only, and the proximal portion is plasma sprayed with commercially pure titanium.

The CS2™ Acetabular Components include acetabular shells and mating liners. The acetabular shells and liners have matching circumferential scallops that rotationally secure the insert in the shell and allow for dialing the insert in a desired orientation. The shells with screw holes have anatomically placed holes, which accommodate optional screws for additional fixation. The shells are manufactured from titanium alloy (Ti-6Al-4V) and are porous coated with either commercially pure titanium sintered or diffusion bonded irregular beads or commercially pure titanium plasma spray. The acetabular shells coated with titanium irregular beads are available in six configurations (1) Hemispherical with three screw holes, (2) Hemispherical with eight to ten screw holes, (3) Hemispherical without screw holes, (4) Flared rim with three screw holes, (5) Flared rim with eight to ten screw holes, and (6) Flared rim without screw holes. The acetabular shells with titanium plasma spray are available in one configuration: hemispherical with three screw holes. The acetabular shells are available in sizes ranging from 42 to 68mm.

The CS2™ and CS2™ PLUS acetabular liners are manufactured from highly cross-linked UHMWPE or highly cross-linked UHMWPE blended with Vitamin-E (VitalitE). The CS2 acetabular liners made from highly cross-linked UHMWPE are available in two configurations: (1) Rimmed neutral and (2) Rimmed hooded. The CS2™ acetabular inserts made from VitalitE are available in four configurations: (1) Rimmed neutral, (2) Rimmed hooded, (3) Rimless neutral, and (4) Rimless hooded. The CS2™ PLUS acetabular inserts are designed with a +5mm lateralized offset and are available in two configurations: (1) Rimmed neutral and (2) Rimmed hooded.

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The Allure Hip Stems are intended to be used in total and partial (hemi-) hip arthroplasty to treat mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. The Allure Hip Stems are intended for uncemented use only.

Indications:

• Primary and secondary osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformities
• Avascular necrosis
• Femoral neck fractures
• Revision surgeries

The Intramedullary Plugs are intended for use with cemented hip stem prostheses to prevent uncontrolled diffusion of bone cement within the medullary canal.

This submission includes the Allure Hip Stems for cementless use and Intramedullary (IM) Plugs for use with cemented hip stem prostheses. Therefore, they are not meant to be used together, but the Allure Stems and the IM Plugs (when used with LINK cemented hip stems) are both used with the same previously cleared LINK systems (Prosthesis Heads and Vario Cups, BiMobile Dual Mobility System, MobileLink Acetabular Cup System) to create hemi-hip or total hip arthroplasty constructs.

The Allure Hip Stem is forged out of a Tilastan-S (Ti6Al4V) alloy. The Prosthesis Stems are proximally equipped with a TiCaP (Titanium-plasma + Calcium Phosphate) coating while the distal tip features a microporous surface with a HX (Calcium Phosphate) coating. The implants are available in different sizes and neck designs, standard or lateralized version and collared or collarless neck, allowing an accurate anatomical match for each patient.

The Allure Hip Stem is part of a mechanical reconstruction of the hip joint. The Allure Hip Stem forms a total hip arthroplasty (THA) when combined with a prosthesis head and an acetabular cup. Alternatively, a hemiarthroplasty (HA) is formed, when combined with the Vario-Cup System. The Hip Stem is intended for uncemented use.

The Intramedullary Plugs are used in combination with cemented implant components.

The Intramedullary Plugs are manufactured from ultrahigh molecular weight polyethylene (UHMWPE), and in sizes from 8 mm to 20 mm.

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• Versafitcup CC TRIO

The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

• Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

• Quadra-P and Quadra-P Collared

The hip prosthesis Quadra-P and Quadra-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The Quadra-P Cemented is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• AMIStem-H, AMIStem-H Collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared

The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.

Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• MiniMAX

The MiniMax is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• Quadra-H and Quadra-R

The hip prosthesis Quadra -S, Quadra-H and Quadra-R is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The hip prosthesis Quadra-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The Quadra-C size 0 implant should not be implanted in patients with a mass of 65 kg or greater.

• SMS and SMS Collared

The hip prosthesis SMS and SMS Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• Mpres

The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.

Total Hip Arthroplasty with the Mpres stem is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head.
• Failure of previous hip surgery:
  • Conservative hip surgery,
  • Internal fixation,
  • Arthrodesis,
  • Hip resurfacing replacement.

Partial hip arthroplasty with the Mpres stem is indicated in the following cases:

• Acute traumatic fracture of the femoral head.
• Avascular necrosis of the femoral head.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.

• Mpact Acetabular Shell

The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

• Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The aim of this submission is to seek clearance for the addition of a new coating supplier for the following coatings:

• Titanium + Hydroxyapatite coating;
• Hydroxyapatite coating;
• Porous Titanium coating for Mpact devices; and
• Titanium coating for Mpact T sizes devices.

The already FDA cleared devices affected by the change are listed in Table 1 below.

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1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.

2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.

3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.

4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.

5. Joint instability resulting from excessive bone resection

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and PSC and intended for cementless use only.

"United" USTAR II System is used for patients who present large quantity of bone loss and deformity associated with previous failed arthroplasty, ligament deficiencies, tumor resection, or trauma and may require a further operation or reconstruction. The USTAR II System includes implanted arthroplasty components of both the USTAR II Knee System and USTAR II Hip System.

For the subject device, it's an extension line of 510(K) cleared device USTAR II System (K190100), which introduces two new variations:

1. Cemented curved stem, RHS, non-coated: diameter 17×200 mm
2. Tibial stem: stem length from 30mm to 150 mm by stem diameter from diameter 9 to diameter 24

The compatibility of cemented curved stem, RHS, non-coated and tibial stem is same as that of the 510(k) cleared USTAR II system (K190100).

Cemented Curved Stem, RHS, non-coated is an extension in terms of sizes to 510 (k) cleared device USTAR II system (K190100). Its design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Cemented Curved Stem, RHS, non-coated.

Tibial stem's design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Tibial Stem while the only difference lies in its specification

Please note: The provided FDA 510(k) clearance letter and summary describe a medical device (Stem Extension Line for the USTAR II System), which is an orthopedic implant. This document does not describe an AI/Software as a Medical Device (SaMD).

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, including details like "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size," and "ground truth establishment for training set," are not applicable to this type of device submission.

The provided text focuses on the mechanical and design equivalence of the new implant variations to a previously cleared predicate device. The "study" mentioned refers to non-clinical mechanical analyses.

Below is an interpretation of the requested points adapted to the context of this orthopedic implant:

Acceptance Criteria and Study for the Stem Extension Line (USTAR II System)

1. Table of Acceptance Criteria and Reported Device Performance

For this orthopedic implant, the acceptance criteria are based on established international standards for the mechanical performance of prosthetic components and demonstrate equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a number of physical implants or test articles in the provided summary. For mechanical testing, typically a defined number of test samples are used per standard, but the specific quantity is not given here.
• Data Provenance: The studies are non-clinical mechanical analyses performed to international standards (ISO, ASTM). The origin of the "data" itself would be the laboratory where these mechanical tests were conducted. It's a prospective design verification process, not a retrospective or prospective clinical study with human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a non-clinical, mechanical device clearance. "Ground truth" in the context of clinical interpretation or diagnosis by experts (e.g., radiologists) is not relevant here. Ground truth is established by standardized material properties, engineering specifications, and mechanical test results per the referenced ISO and ASTM standards. Experts involved would be engineers and material scientists responsible for the design, testing, and analysis, ensuring compliance with manufacturing and performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 typically refer to consensus readings or evaluations by multiple human experts in studies involving subjective interpretation (e.g., imaging, clinical outcomes). For mechanical testing, the results are quantitative and objective, measured against predefined acceptance criteria from engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. MRMC studies are specific to evaluating the clinical performance of diagnostic aids, particularly those involving human interpretation, and are commonly used for AI/ML in medical imaging. This submission concerns the mechanical safety and functionality of an orthopedic implant. No human reader involvement or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human input. This device is a physical orthopedic implant, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this type of device is based on engineering standards and specifications. This includes:
  • Material properties: Verifying components meet specified material strengths and compositions.
  • Geometric tolerances: Ensuring dimensions align with design specifications.
  • Mechanical performance: Demonstrating the implant can withstand anticipated loads and stresses as defined by the ISO and ASTM test standards (e.g., fatigue life, static strength).
  • Equivalence to Predicate Device: The primary "ground truth" is that the new variations perform equivalently to or better than the already cleared predicate device under the same test conditions.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device where a "training set" of data is used to develop an algorithm. The "design" and "manufacturing process" are based on established engineering principles and prior validated designs (the predicate device).

9. How the ground truth for the training set was established

• Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this physical device, there is no method for establishing its "ground truth." The design and manufacturing processes are validated through engineering analyses and quality control processes to meet the required specifications and standards.

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