(79 days)
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.
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.
The provided text is a "Summary of Safety and Effectiveness" for a medical device (Cement-On Femoral Stem). It describes the device, its intended use, potential risks, and claims substantial equivalence to other devices on the market. However, this document does not contain the specific information required to describe acceptance criteria and a study proving those criteria are met.
Here's why and what's missing:
- Acceptance Criteria: The document mentions "potential risks" but does not define specific, quantifiable acceptance criteria (e.g., minimum tensile strength, maximum wear rate, specific clinical success rates, etc.) that the device must meet.
- Study Details: While it implies equivalence to other devices, it doesn't describe a specific study that evaluated the performance of this particular device against defined acceptance criteria. There's no mention of sample size, data provenance, ground truth establishment, expert involvement, or statistical results.
Therefore, I cannot populate the requested table and answer the questions based only on the provided input.
To answer your request, I would need a different document, such as a clinical study report, a design verification and validation report, or a regulatory submission that includes performance data and acceptance criteria.
If such a document were provided, I would look for sections detailing:
- Performance Specifications/Acceptance Criteria: Often found in design control documents or regulatory submissions.
- Clinical Study or Bench Test Results: Specifically, data that directly addresses the performance metrics.
- Study Design: Information on sample size, patient population (for clinical studies), data collection methods.
- Ground Truth: How outcomes were determined (e.g., based on expert consensus, pathology, long-term follow-up).
- Reader Studies: If applicable, details on MRMC studies.
Without this information, any attempt to fulfill your request would be speculative and not based on the provided text.
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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
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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)
§ 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.