(69 days)
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No
The summary describes a mechanical implant (tibial tray) and does not mention any software, algorithms, or data processing related to AI/ML.
No.
The device is a component for surgical implantation in total knee arthroplasty, not a therapeutic device that delivers therapy or treatment directly.
No.
The device is described as a tibial tray used as a component in knee arthroplasty, indicating it is an implantable prosthetic device, not a diagnostic tool.
No
The device description clearly states it is a physical tibial tray made of cast cobalt chrome, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used as the tibial component in cemented total knee arthroplasty." This describes a surgical implant used in the body, not a device used to examine specimens outside the body (in vitro).
- Device Description: The description details a physical implant (a tibial tray) made of cobalt chrome, with a stem and fins. This is consistent with a surgical implant.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a prosthetic implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The DcPuy AMK Porous Coated CRX Tibial Tray is intended to be used as the tibial component in cemented total knee arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
87 JWH
Device Description
The DePuy AMK Porous Coated CRX Tibial Tray is a cast cobalt chrome tibial tray available in four standard sizes and five "plus" tibial sizes. The tray has a fixed, tapered, cylindrical central stem and two posterior fins originating at the central stern, and porous coating on the undersurface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Depuy AMK Cemented CRX Tibial Tray, DePuy Synatomic Variable Fit Tibial Plateau, Howmedica PCA Modular Stemmed Tibial Baseplate
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
06 12/96 08:32 2219 267 7045
JUN 18 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
NAME OF FIRM:
DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
FIRM CONTACT:
Sally Foust Clinical Research Specialist
DePuy AMK Porous Coated CRX Tibial Tray TRADE NAME:
COMMON NAME:
CLASSIFICATION:
Knee Prosthesis
888.3560 Knee joint patchlofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis
DEVICE PRODUCT CODE: 87 JWH
SUBSTANTIALLY EQUIVALENT DEVICES:
Depuy AMK Cemented CRX Tibial Tray DePuy Synatomic Variable Fit Tibial Plateau Howmedica PCA Modular Stemmed Tibial Baseplate
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy AMK Porous Coated CRX Tibial Tray is a cast cobalt chrome tibial tray available in four standard sizes and five "plus" tibial sizes. The tray has a fixed, tapered, cylindrical central stem and two posterior fins originating at the central stern, and porous coating on the undersurface. The DcPuy AMK Porous Coated CRX Tibial Tray is intended to be used as the tibial component in cemented total knee arthroplasty.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy AMK Porous Coated CRX Tibial Tray is identical to the DePuy AMK Cemented CRX Tibial Tray cleared as the tibial component in cemented total knee arthroplasty except for the addition of the undersurface porous coating and the option of a tibial tray with screw holes.
Both the DePuy AMK Porous Coated and Cemented CRX Tibial Trays are manufactured from Co-Cr-Mo alloy and are available in four standard and five "plus" tibial sizes. Both have a fixed, tapered, cylindrical stem and two posterior fins originating at the central stem. The intended use (cemented total knee arthroplasty) of the AMK Porous Coated CRX Tibial Tray is identical to that of the DePuy AMK Cemented CRX Tibial Tray.
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