(284 days)
No
The summary describes a physical implantable device (tibial insert) made of polyethylene with no mention of software, algorithms, or data processing, which are typically associated with AI/ML in medical devices.
Yes
The device is a PCL substituting tibial insert, used for primary intervention of various forms of arthritis and replacement of unsatisfactory knee components. It is a medical implant designed to treat a medical condition.
No
The device described is a Consensus® PCL Substituting Tibial Insert, which is a medical implant used in knee replacement surgery. Its purpose is to substitute a part of the knee joint, not to diagnose a condition.
No
The device description clearly states it is a physical component manufactured from ultra-high molecular weight polyethylene, designed to be implanted in the knee. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The Consensus® PCL Substituting Tibial Insert is a physical implant designed to be surgically placed within the knee joint. It does not analyze or test any biological samples.
- The intended use is for surgical intervention and replacement of knee components. This is a therapeutic and structural device, not a diagnostic one.
- The device description focuses on materials and design for articulation within the knee. This is consistent with a surgical implant.
The information provided clearly describes a medical device intended for surgical implantation to treat knee conditions, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Consensus® PCL Substituting Tibial Insert is indicated for use in:
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- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
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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
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance Data: The device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Key Metrics
Not Found
Predicate Device(s)
Intermedics Orthopedics, Inc. Natural Knee® Ultracongruent Tibial Insert K912663
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
955 - 1 5 5 5
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.
1
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