(79 days)
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No
The document describes a mechanical implant (femoral stem) and its intended use, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is clearly indicated for treating painful and disabled knee joints resulting from various arthritic conditions, failure of previous joint replacements, and correction of deformities. These indications align with the definition of a therapeutic device.
No
This device is a Cement-On Femoral Stem, an implant used in knee replacement procedures to enhance fixation of the prosthesis. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a physical implant (Co-Cr &mm distal augment with an attached 120mm long intramedullary stem) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device, the Cement-On Femoral Stem, is an implantable medical device used in surgical procedures to replace or augment a damaged knee joint. It is a physical component implanted into the patient's body.
The description clearly indicates its use in surgical procedures for treating knee joint conditions, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
When used with the AGC and Maxim Knee systems, the indications for use of the Cement-On Femoral Stem include: 1) painful and disabled knee joint resulting from osteoarthrits, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity and 4) correction of unsuccessful osteotomy or arthrodesis.
This device is for use with bone cement.
Product codes
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Device Description
The Cement-On Femoral Stem enhances fixation of prothesis to bone while still being able to maintain the posterior cruciate ligament. The stem is indicated when the soft tissues of the knee are intact but significant bony loss or fracture warrents the use of an intramedullary stem.
The Cement-On Femoral Stem is a Co-Cr &mm distal augment with an attached 120mm long intramedullary stem. The stem is angled at 7 · valgus and is fixed to the surface of the primary femoral component with bone cement.
The device is to be used with the appropriate AGC and Maxim knee components and is available in six different sizes.
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)
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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
Image /page/0/Picture/0 description: The image shows the logo for Biomet Inc. The logo is in black and white and features a stylized "BIOMET" in a bold, sans-serif font. The letters are interconnected, and the "B" is enclosed in a square. The letters "INC" are stacked vertically to the right of the word Biomet, and there is a registered trademark symbol in the upper right corner of the logo.
DEC - 4 1996
Corporate Headquarters
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587
Shipping Address: Airport Industrial Park Warsaw, IN 46580
(219) 267-8137 FAX
SUMMARY OF SAFETY AND EFFECTIVENESS (219) 267-6639 Office
- Sponsor: Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw. IN 46581-0587
K963709
Cement-On Femoral Stem Device:
Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Classification Name: Constrained Cemented Prothesis (CFR 888.3560)
Intended Use: When used with the AGC and Maxim Knee systems, the indications for use of the Cement-On Femoral Stem include: 1) painful and disabled knee joint resulting from osteoarthrits, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity and 4) correction of unsuccessful osteotomy or arthrodesis.
This device is for use with bone cement.
Device Description: The Cement-On Femoral Stem enhances fixation of prothesis to bone while still being able to maintain the posterior cruciate ligament. The stem is indicated when the soft tissues of the knee are intact but significant bony loss or fracture warrents the use of an intramedullary stem.
The Cement-On Femoral Stem is a Co-Cr &mm distal augment with an attached 120mm long intramedullary stem. The stem is angled at 7 · valgus and is fixed to the surface of the primary femoral component with bone cement.
The device is to be used with the appropriate AGC and Maxim knee components and is available in six different sizes.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
-
Reaction to the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Inplant loosening/migration Nerve damage
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the component -
Bone Fracture Infection Hematoma Dislocation Excessive wear
1
Substantial Equivalence: In function and overall design, the Cement-On Femoral Stem is equivalent to other knee components on the market. These stems include:
AGC 2000 Total Knee Prothesis (Biomet, Inc., Warsaw, IN) Maxim Knee System(Biomet, Inc., Warsaw, IN) Kinemax Plus Total Knee System (Howmedica, Rutherford, New Jersey)
Genesis Total Knee System (Richards, Memphis, TN)