(284 days)
The Consensus® PCL Substituting Tibial Insert is indicated for use in:
-
- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
-
- Failed osteotomy or unicompartmental replacements
-
- Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
The Consensus® Knee PCL Substituting Tibial Insert component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is an asymmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each 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 Consensus® PCL Substituting Tibial Insert will be provided sterile.
The provided text describes a medical device, the Consensus® PCL Substituting Tibial Insert, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.
Specifically, the document states:
- "Performance Data: The device performs with substantial equivalence to predicate devices."
- "Clinical Data: None Required"
- "Conclusions from Non-clinical and Clinical Data: The Consensus® PCL Substituting Tibial Insert is substantially equivalent to the predicate device."
This indicates that the regulatory approval was based on demonstrating equivalence to an already approved device, rather than explicit acceptance criteria and corresponding performance metrics from a dedicated study of the Consensus® PCL Substituting Tibial Insert itself.
Therefore, I cannot populate the requested table or provide details about a study proving the device meets acceptance criteria, as that information is not present in the provided text.
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APR 2 6 1996
ATTACHMENT 8 (Amended 10/17/95)
Summary of Safety and Effectiveness
510(k) SUMMARY
US MEDICAL PRODUCTS, INC. CONSENSUS® PCL SUBSTITUTING TIBIAL INSERT
US Medical Products, Inc. 12201 Technology Boulevard Suite 100 Austin. Texas 78727 Fax
William N. Thompson, Director Quality Assurance and Regulatory Affairs Voice (512) 257-4835 (512) 257-8300 Date of Preparation: 17 Oct 1995
Trade Name: Consensus® PCL Substituting Tibial Insert
Common Name: posterior cruciate ligament substituting tibial insert knee prosthesis
Classification Name: Prosthesis, knee, patello/femorotibial, semi-constrained, cemented, polymer/metal/polymer, under classification 21CFR888.3560.
Substantial Equivalence: equivalent PCL Substituting Tibial Insert component:
Intermedics Orthopedics, Inc. Natural Knee® Ultracongruent Tibial Insert K912663 SE 09-16-91
- Device Description: The Consensus® Knee PCL Substituting Tibial Insert component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is an asymmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each 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 Consensus® PCL Substituting Tibial Insert will be provided sterile.
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The Consensus® PCL Substituting Tibial Insert is designed for use with the following Consensus® Total Knee System components:
Consensus® Nonporous CoCr Femoral component
Consensus® Porous CoCr Femoral Component
Consensus® All Poly Patellar component
Consensus® Metal Back Patellar component
Consensus® Porous Titanium Stemmed Tibial Baseplate
Consensus® Nonporous Titanium Stemmed Tibial Baseplate
Consensus® CoCr Stemmed Tibial Baseplate
Intended Use: The Consensus® PCL Substituting Tibial Insert is indicated for use in:
-
- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
-
- Failed osteotomy or unicompartmental replacements
-
- Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
Summary of Technological Characteristics: The Consensus® PCL Substituting Tibial Insert is an asymmetric UHMWPE cruciate-substituting tibial component designed to articulate with the Consensus® Knee primary femoral component. The inferior surface of each 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.
Performance Data: The device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Conclusions from Non-clinical and Clinical Data: The Consensus® PCL Substituting Tibial Insert is substantially equivalent to the predicate device.
Other Necessary Information: None Required
§ 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.