(215 days)
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No
The device description focuses on the materials and mechanical design of a knee implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a knee replacement system used to treat conditions like arthritis and failed joint replacements, which are therapeutic interventions.
No.
The provided text describes a Consensus® Posterior Stabilized Knee, which is an orthopedic implant used for knee replacement surgery, not a diagnostic tool. Its intended use involves treating conditions like arthritis or failed previous surgeries, and its components are designed for articulation and stability within the knee joint.
No
The device description clearly details physical components made of materials like UHMWPE and CoCrMo alloy, indicating it is a hardware medical device (a knee implant system).
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 for replacing damaged knee joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a knee prosthesis (femoral component, tibial insert) made from materials like UHMWPE and CoCrMo alloy. These are materials used in surgical implants, not for in vitro testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Anatomical Site: The device is used directly on the knee joint within the body, not for testing samples outside the body.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Consensus® Posterior Stabilized Knee is indicated for use in:
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- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis in the absense of the posterior cruciate ligament.
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- Failed osteotomy or unicompartmental replacements
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- Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
Product codes
21CFR888.3560
Device Description
The Consensus® PS Knee tibial insert component is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648), and is designed to articulate with the Consensus® PS femoral component. The insert has a spine on the central eminence which engages the crossbar of the PS femoral component. The spine is positioned so that the crossbar of the PS femoral component engages at approximately 65° flexion. The inferior surface of each component employs dovetail grooves for positive interlocking with the Consensus® Primary Knee tibial baseplate. The design is available in three sizes and each size is available in five thicknesses.
The Consensus® PS Femoral component is made of CoCrMo alloy (ASTM F75). Both the outer articulating surface and the inner box geometry of the Consensus® PS femoral component are identical to the respective surfaces of the Consensus® Primary Knee femoral component. Therefore, the PS femoral component contains the same deepened patella groove as the Consensus® Primary Knee femoral component for increased range of motion, utilizes the same instrumentation as the Consensus® Knee for preparing the distal femur, and employs smooth distal pegs for added Medial/Lateral stability. The Consensus® PS femoral component has a shortened patella groove to accommodate the spine of the Consensus® PS tibial insert. It also contains a stabilizing bar located between the posterior condyles which engages the spine of the Consensus® PS tibial insert at high flexion angles.
The Consensus® Posterior Stabilized Knee System will be provided sterile.
The Consensus® Posterior Stabilized Knee is designed for use with the following Consensus® Total Knee System components:
Consensus® All Poly or metal back Patellar component
Consensus® Porous Titanium Stemmed Tibial Baseplate
Consensus® Nonporous Titanium Stemmed Tibial Baseplate
Consensus® CoCr Stemmed Tibial Baseplate
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee
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)
Performance Data: The device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Conclusions from Non-clinical and Clinical Data: The Consensus® PS Knee is substantially equivalent to the predicate device.
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.
Johnson&Johnson PFC® Modular Knee System, K884796
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.
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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
MAY 2 2 1996
954818
ATTACHMENT 8
Summary of Safety and Effectiveness
SUMMARY 510(k)
US MEDICAL PRODUCTS, INC. CONSENSUS® Posterior Stabilized Knee System
US Medical Products, Inc. 12201 Technology Boulevard Suite 100 Austin, Texas 78727
William N. Thompson, Director Quality Assurance and Regulatory Affairs Voice (512) 257-4835 Fax (512) 257-8300 Date of Preparation: 15 Oct. 1995
Consensus® Posterior Stabilized Knee prosthesis Trade Name:
Common Name: Posterior cruciate ligament sacrificing knee prosthesis; PS Knee
Classification Name: Prosthesis, knee, patello/femorotibial, semi-constrained, cemented, polymer/metal/polymer, under classification 21CFR888.3560.
Substantial Equivalence: equivalent Posterior Stabilized Knee components:
Johnson&Johnson PFC® Modular Knee System, K884796, SE 03-29-89.
Device Description: The Consensus® PS Knee tibial insert component is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648), and is designed to articulate with the Consensus® PS femoral component. The insert has a spine on the central eminence which engages the crossbar of the PS femoral component. The spine is positioned so that the crossbar of the PS femoral component engages at approximately 65° flexion. The inferior surface of each component employs dovetail grooves for positive interlocking with the Consensus® Primary Knee tibial baseplate. The design is available in three sizes and each size is available in five thicknesses.
The Consensus® PS Femoral component is made of CoCrMo alloy (ASTM F75). Both the outer articulating surface and the inner box geometry of the Consensus® PS femoral component are identical to the respective surfaces of the Consensus® Primary Knee femoral component. Therefore, the PS femoral component contains the same deepened
1
patella groove as the Consensus® Primary Knee femoral component for increased range of motion, utilizes the same instrumentation as the Consensus® Knee for preparing the distal femur, and employs smooth distal pegs for added Medial/Lateral stability. The Consensus® PS femoral component has a shortened patella groove to accommodate the spine of the Consensus® PS tibial insert. It also contains a stabilizing bar located between the posterior condyles which engages the spine of the Consensus® PS tibial insert at high flexion angles.
The Consensus® Posterior Stabilized Knee System will be provided sterile.
The Consensus® Posterior Stabilized Knee is designed for use with the following Consensus® Total Knee System components:
Consensus® All Poly or metal back Patellar component Consensus® Porous Titanium Stemmed Tibial Baseplate Consensus® Nonporous Titanium Stemmed Tibial Baseplate Consensus® CoCr Stemmed Tibial Baseplate
The Consensus® Posterior Stabilized Knee is indicated for use in: Intended Use:
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- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis in the absense of the posterior cruciate ligament.
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- Failed osteotomy or unicompartmental replacements
-
- Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
The Consensus® PS Tibial Insert is an Summary of Technological Characteristics: asymmetric UHMWPE cruciate-sacrificing tibial component designed to articulate with the Consensus® PS Femoral component, and the Consensus® Primary Knee patellar components. The inferior surface of the tibial component employs dovetail grooves for positive interlocking with the tibial baseplate. The design is available in three sizes and each size is available in five thicknesses. The PS Femoral component is asymmetric, with a shortened patella groove to accommodate the spine of the PS tibial insert, and contains a stabilizing bar located between the posterior condyles which engages the spine of the PS tibial insert. It is available in six sizes.
Performance Data: The device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Conclusions from Non-clinical and Clinical Data: The Consensus® PS Knee is substantially equivalent to the predicate device.
Other Necessary Information: None Required