(57 days)
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No
The summary describes a physical medical device (a tibial insert) and its mechanical properties and intended use, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is a tibial insert used to treat various knee joint conditions like osteoarthritis, rheumatoid arthritis, and post-traumatic loss of joint configuration. Its purpose is to alleviate symptoms, improve joint function, and treat diseases, which falls under the definition of a therapeutic device.
No
The device description and intended use focus on treatment and physical articulation within a joint, not on identifying a disease or condition. It's a prosthetic component, not a tool for diagnosis.
No
The device description clearly describes a physical component (tibial insert) used in knee replacement surgery, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of various knee joint conditions through surgical implantation. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical component (a tibial insert) designed to be implanted in the body to improve joint function. This is consistent with a medical device used for treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis. IVDs are specifically designed for these purposes.
Therefore, this device falls under the category of a medical device used for surgical intervention and treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use of this tibial insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.
Product codes
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Device Description
This component is available in seven sizes to fit into, and articulate with, the existing Foundation Baseplates and Femoral Components. This device is used in conjunction with the Foundation® Tibial Baseplates and Femurs. This insert is intended to provide more congruency between the insert and femur than is available with the primary insert. However, it will provide similar, or slightly more, congruency than the Foundation® Posterior Stabilized Knee. Anterior/posterior stability is greater than the primary insert because of the increased height of the anterior and posterior lips. Rotational stability is similar to the primary insert.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 8900 Shoal Creek BLVD. Suite 300 Austin, TX 78757 512-206-1437 Ashley M. Bock
Trade Name; Tibial Insert
Common Name: Tibial Insert
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis
Description: This component is available in seven sizes to fit into, and articulate with, the existing Foundation Baseplates and Femoral Components. This device is used in conjunction with the Foundation® Tibial Baseplates and Femurs. This insert is intended to provide more congruency between the insert and femur than is available with the primary insert. However, it will provide similar, or slightly more, congruency than the Foundation® Posterior Stabilized Knee. Anterior/posterior stability is greater than the primary insert because of the increased height of the anterior and posterior lips. Rotational stability is similar to the primary insert.
Indications: The indications for use of this tibial insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.
Comparable Features to Predicate Device(s): This device is similar in features, design and indications as the Foundation® Primary Knee System (K923277) and Foundation® Posterior Stabilized Tibial Inserts. (K933539)