(76 days)
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No
The description focuses on mechanical design modifications of a knee replacement system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a knee replacement system, which aims to replace a damaged joint, not treat or cure a disease. It is a prosthetic device.
No
The document describes a knee replacement system, which is a prosthetic device used for surgical implantation, not for diagnosing a condition.
No
The device description clearly outlines physical components (stem extensions, central posts, tibial trays, tibial inserts) made from materials like Co-Cr-Mo, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The DePuy Coordinate II Revision Knee System is a surgical implant designed to replace a knee joint. It is used in the body, not to test samples from the body.
- Intended Use: The intended use clearly states it's a "tricompartmental knee replacement system," which is a surgical procedure.
Therefore, based on the provided information, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DePuy Coordinate II Revision Knee System is indicated for use with bone cement as either a primary or revision tricompartmental knee replacement system.
Product codes
87 JWH
Device Description
The Coordinate II Revision Knee System is a design modification of the Coordinate Revision Knee System which was previously cleared by FDA for cemented use. The design modifications consist of the following: stem extensions for femoral and tibial components will be threaded rather than tapered; central posts on the femoral components and tibial trays will be modified to accept the threaded stem extensions; all tibial trays will be manufactured from cast Co-Cr-Mo; and the articular surface of the tibial inserts will be modified to be slightly more conforming.
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
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)
DePuy AMK Landmark Revision Knee System and Full Wedge Tibial Tray (renamed the Coordinate Revision Knee System), Johnson & Johnson P.F.C. Modular Knee System, DePuy Synatomic Variable Fit Tibial Plateau, DePuy AMK Congruency PS Tibial Inserts
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl Hastings
Manager, Pre-clinical Device Evaluation |
| TRADE NAME: | DePuy Coordinate II Revision Knee System |
| COMMON NAME: | Knee Prosthesis |
| CLASSIFICATION: | 888.3560 - Prosthesis, knee, patellofemorotibial,
semi-constrained, cemented, polymer/metal/polymer |
| DEVICE PRODUCT CODE: | 87 JWH |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | • DePuy AMK Landmark Revision Knee System
and Full Wedge Tibial Tray
(renamed the Coordinate Revision Knee System)
• Johnson & Johnson P.F.C. Modular Knee System
• DePuy Synatomic Variable Fit Tibial Plateau
• DePuy AMK Congruency PS Tibial Inserts |
INTENDED USE AND DEVICE DESCRIPTION:
The Coordinate II Revision Knee System is a design modification of the Coordinate Revision Knee System which was previously cleared by FDA for cemented use. The design modifications consist of the following: stem extensions for femoral and tibial components will be threaded rather than tapered; central posts on the femoral components and tibial trays will be modified to accept the threaded stem extensions; all tibial trays will be manufactured from cast Co-Cr-Mo; and the articular surface of the tibial inserts will be modified to be slightly more conforming.
The DePuy Coordinate II Revision Knee System is indicated for use with bone cement as either a primary or revision tricompartmental knee replacement system.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Coordinate II Revision Knee System is similar to the Coordinate Revision Knee System previously cleared by FDA with the exception of the design change listed under DEVICE DESCRIPTION.
The material, manufacturing process, intended use (cemented total knee arthroplasty) and the basic design of the Coordinate II Revision Knee System, including sizes of femoral components, tibial trays, and tibial inserts will not be changed from those of the Coordinate Revision Knee System previously cleared by FDA.
lol
C03016