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Smith & Nephew Total Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use.

Indications for Cruciate Retaining Cemented Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   Cruciate Retaining Cemented Knee components are indicated for use with cement and are single use devices.

Indications for Cruciate Retaining Cementless Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   Cruciate Retaining Cementless Knee components are indicated for use without cement and are single use devices.

Indications for Posterior Stabilized Cemented Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Posterior Stabilized Cemented Knee components are indicated for use with cement and are single use devices.

Indications for Posterior Stabilized Cementless Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Posterior Stabilized Cementless Knee components are indicated for use without cement and are single use devices.

Indications for Constrained Total Knees:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
   Constrained Total Knee components are indicated for use with cement and are single use devices.

Indications for Hinged Total Knees:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
5. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
   Hinged Total Knee components are indicated for use with cement and are single use devices.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Total Knee System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use. Smith & Nephew Total Knee System Instruments can be organized into instrument families which are categorized as follows: Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment and Sizing Instruments, Impactors and Handles, Clamps, Extraction, Torque, Instrument Guides, and Covers and Protectors.

This document is a 510(k) Summary of Safety and Effectiveness for the Smith & Nephew Total Knee System Instruments. It explicitly states that these instruments are "accessory devices" used to assist in the implantation of Smith & Nephew Total Knee Systems.

The document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any AI-related performance metrics.

The content is focused on:

• Device classification and regulatory information.
• Listing predicate devices (previously cleared knee systems).
• Device description (types of instruments).
• Intended use and Indications for Use for various knee replacement types (Cruciate Retaining, Posterior Stabilized, Constrained, Hinged).
• FDA clearance letter.

Therefore, I cannot provide the requested information. The document is for mechanical surgical instruments, not an AI/Software as a Medical Device (SaMD) that would typically involve performance studies with ground truth and expert reviews for diagnostic accuracy.

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Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.

The Patient Matched Cutting Blocks are intended for use with existing Smith & Nephew, Inc. knee systems and their cleared indications for use.

The Patient Matched Cutting Blocks are intended for single use only.

Subject of this premarket notification are Smith & Nephew's Patient Matched Cutting Blocks. The Patient Matched Cutting Blocks are designed and manufactured from patient imaging data (MRI, CT, X-Ray).

This 510(k) submission for Smith & Nephew's Patient Matched Cutting Blocks is for a physical medical device (patient-specific surgical instrumentation) and not an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, training set, and ground truth establishment, are not applicable here.

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The Competitor Duo Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.

Indications include:

• post-traumatic arthritis; .
• degenerative arthritis; and .
• failed osteotomies, hemiarthroplasties; and unicompartmental replacement .

These indications will be used for the Competitor Duo Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Competitor Duo Knee Femoral Components are single use only and are intended for implantation only with bone cement

The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Duo will include both CoCr and Oxinium femorals. The overall Knee joint. The Competitor Duo femoral component are based upon the existing Hybrid Knee Femoral Component subject of K042896.

This document is a 510(k) summary for a medical device (Competitor Duo Knee Femoral Components), which focuses on demonstrating substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies for AI/algorithm performance.

Therefore, I cannot provide the requested information. This type of regulatory submission historically does not involve such data as it is for mechanical devices demonstrating equivalence, not AI/software performance evaluations.

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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. High Performance Knee components are indicated for use only with cement and are single use devices.

The High Performance Knee consists of femoral, tibial insert and patellar components to be used with existing Genesis II tibial trays. The High Performance Knee is a total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range.

The provided text describes a medical device, the "High Performance Knee," and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria for a study, a study that proves the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in such a study.

The document is a summary of safety and effectiveness, along with the FDA's 510(k) clearance letter. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document explicitly states:

"A review of the mechanical test data indicated that the High Performance Knee is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

This statement implies that mechanical testing was performed, but it does not provide the specific "acceptance criteria" for that testing, the detailed "reported device performance" against those criteria, or any of the other study details requested. The focus is on demonstrating equivalence, not on a new performance study with independent acceptance criteria.

Missing Information:
All requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC studies, or standalone performance is not present in the provided text.

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