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K Number
K953443
Device Name
CONSENSUS PCL SUBSITUTING TIBIAL INSERT
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-04-26

(284 days)

Product Code
JWH
Regulation Number
888.3560
Type
Traditional
Panel
OR
Reference & Predicate Devices
K912663
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Consensus® PCL Substituting Tibial Insert is indicated for use in:

    1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
    1. Failed osteotomy or unicompartmental replacements
    1. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
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.

AI/ML Overview

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.

§ 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.