(81 days)
Not Found
No
The summary describes a mechanical implant (femoral insert) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a femoral insert for a knee system used to treat various degenerative joint diseases and arthritis, which are conditions that benefit from therapeutic intervention to restore function and alleviate symptoms.
No
Explanation: The device description indicates that this is a femoral component designed to fit into and articulate with an existing knee system, and the intended use describes conditions for which this component is used as a treatment. This indicates it is a therapeutic device (an implant), not a diagnostic device.
No
The device description clearly describes a physical femoral component made of CoCr alloy with titanium coating and pegs, which is a hardware implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a "femoral component" and a "femoral insert" designed to be implanted into the knee joint. It is a physical implant used in surgery.
- Intended Use: The intended uses are all related to treating conditions affecting the knee joint through surgical intervention and implantation.
There is no mention of this device being used to test samples from the body or to provide diagnostic information based on such tests. It is a therapeutic device used to replace or augment a damaged part of the body.
N/A
Intended Use / Indications for Use
The indications for use of this femoral 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 (comma separated list FDA assigned to the subject device)
Not Found
Device Description
This femoral component is available in six sizes, to fit into, and articulate with, the existing Foundation® Knee System. The CoCr alloy (ASTM F75) component is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance fixation. The femoral component has two smooth pegs to provide medial/lateral stability.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Encore Orthopedics®, Inc. 8900 Shoal Creek BLVD. Suite 300 Austin, TX 78757 512-206-1437 Ashley M. Bock
DEC 2 7 1996
Trade Name: Femoral Component
Common Name: Femoral Component
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis.
Description: This femoral component is available in six sizes, to fit into, and articulate with, the existing Foundation® Knee System. The CoCr alloy (ASTM F75) component is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance fixation. The femoral component has two smooth pegs to provide medial/lateral stability.
Indications: The indications for use of this femoral 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 Biomet Maxim® Knee System.