(86 days)
P.F.C.® Σ Sigma Knee System
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No
The description focuses on the mechanical design and materials of a knee implant, with no mention of AI or ML.
Yes
The device is indicated for patients suffering from severe pain and disability due to permanent structural damage, aiming to alleviate these symptoms and improve function.
No
Explanation: The device is a knee implant, described as a P.F.C. Sigma Knee System, indicated for use with bone cement for patients with severe pain and disability due to permanent structural damage in the knee. It is a treatment device, not one used for diagnosis.
No
The device description explicitly states the device is constructed of UHMWPE and Titanium, indicating it is a physical implant and not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to treat severe pain and disability in the knee joint due to various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a knee implant (tibial insert, materials like UHMWPE and Titanium). It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) which is characteristic of IVDs.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological samples
- Detection or measurement of analytes
- Diagnostic purposes (identifying a disease or condition)
- Laboratory testing
In summary, the P.F.C. Sigma Knee System is a surgical implant designed to replace damaged knee joints, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The P.F.C. Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
Product codes
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Device Description
The Stabilized Plus tibial insert components are used with the existing components of the P.F.C.® Sigma Knee System. The Stabilized Plus tibial insert components have a symmetrical design which can be used for either the left or right knee. The Stabilized Plus tibial insert components have an anterior and posterior snap feature and a reinforcing pin to ensure adequate interlock to the tibial tray. The tibial insert attachment mechanism is identical to the existing TC3 tibial inserts. The Stabilized Plus tibial insert and femoral condylar geometry allow for mixing and matching of sizes: up one size, size to size, and down one size. The device is constructed of UHMWPE, and Titanium.
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)
P.F.C.® Σ Sigma Knee System
Reference Device(s)
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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).
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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
510(k) Summarv August 9. 1996
NOV -6 1996
Johnson & Johnson Professional. Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person: John Ferros Phone: 508.880.8287
Name of Device
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis has been placed in Class II by the FDA under 21 CFR 888.3560. This falls under the Orthopaedics panel/87. Common Name: Semi-constrained total knee prosthesis.
Trade Name/Proprietary Name: P.F.C. Sigma Knee System (Stabilized Plus)
Performance Standards: No performance standards have been developed for this device.
Predicate Device
P.F.C.® Σ Sigma Knee System Description of Device
The Stabilized Plus tibial insert components are used with the existing components of the P.F.C.® Sigma Knee System. The Stabilized Plus tibial insert components have a symmetrical design which can be used for either the left or right knee. The Stabilized Plus tibial insert components have an anterior and posterior snap feature and a reinforcing pin to ensure adequate interlock to the tibial tray. The tibial insert attachment mechanism is identical to the existing TC3 tibial inserts. The Stabilized Plus tibial insert and femoral condylar geometry allow for mixing and matching of sizes: up one size, size to size, and down one size. The device is constructed of UHMWPE, and Titanium.
Intended Use
The P.F.C. Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
Technological Characteristics Compared to Predicate Device
All technical characteristics are identical to the Predicate Device. The P.F.C.® Sigma Knee System (Stabilized Plus) is identical to the Predicate device except we are introducing the Stabilized Plus tibial insert components.