(90 days)
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:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- 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:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- 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:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- 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:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- 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:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- 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:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- 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 incompetent and the collateral ligaments remain intact.
- 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.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.