(188 days)
Harris/Galante Porous Total Hip, Enhanced Modular Austin Moore Hip Prosthesis, HG MultiLock™ Hip Prosthesis With Ti-Nidium® Surface Hardening Process, MG II® Total Knee System with Ti-Nidium Surface Hardening Process
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No
The summary describes a mechanical implant (femoral head) and its material properties and performance in wear, corrosion, and fatigue testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The femoral heads are intended for use in total and hemi-hip arthroplasty procedures, which are therapeutic interventions to replace a damaged hip joint.
No
The provided text describes femoral heads used in hip arthroplasty procedures. These devices are replacement components for the hip joint, designed for mechanical function and wear resistance, not for detecting, monitoring, or diagnosing diseases or conditions.
No
The device description clearly indicates a physical implant (femoral heads) made of metal alloys, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The provided description clearly states that the device is a "Femoral head," which is a component of a hip implant used in surgical procedures. It is a physical implant placed inside the body.
- Intended Use: The intended use is for "total and hemi-hip arthroplasty procedures," which are surgical procedures to replace the hip joint. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
Femoral heads are single-use devices that are mated via a press-fit tapered neck with titanium or cobalt-chrome alloy femoral stems in total and hemi-hip arthroplasty procedures.
Product codes
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Device Description
The design of the femoral heads includes a spherical head portion that is highly polished and processed with the Co-Nidium surface treatment. Femoral heads for total hip arthroplasty procedures are available in diameters from 22 to 32 mm with varying neck lengths. Femoral heads for hemi-hip arthroplasty procedures are available in 38 to 63 mm outer diameters. The femoral heads include a tapered portion that fits securely onto a modular femoral stem component.
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
Hip Joint
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
Wear testing demonstrated improved abrasive wear resistance when compared to the predicate device. Corrosion testing demonstrated that the breakdown potential of the alloy material is not changed by surface hardening. Fatigue testing indicated that the fatigue strength of the nitrided alloy is higher than the fatigue strength of currently marketed devices. Dimensional analysis and coefficient of friction data showed no change for the nitrided femoral heads. Microhardness and ESCA data exhibited higher hardness and depth of hardening when compared to the predicate device.
Key Metrics
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Predicate Device(s)
--Harris/Galante Porous Total Hip, Enhanced Modular Austin Moore Hip Prosthesis, HG MultiLock™ Hip Prosthesis With Ti-Nidium® Surface Hardening Process, MG II® Total Knee System with Ti-Nidium Surface Hardening Process
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font, with all letters in lowercase.
JUL 25 1996
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness Cobalt-Chromium-Molybdenum Alloy Femoral Heads with Co-Nidium™ Surface Hardening Process
-
Submitted by:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 -
Prepared by: .
Lynnette Whitaker, RAC Manager Regulatory Affairs -
Date: .
January 17, 1996 -
Trade Name:
Cobalt-Chromium-Molybdenum (Co-Cr-Mo) Alloy Femoral Heads with Co-Nidium Surface Hardening Process -
Classification Name: .
Hip Joint Metal/Polymer Semiconstrained Cemented Prosthesis -
Predicate Devices: .
- --Harris/Galante Porous Total Hip
- Enhanced Modular Austin Moore Hip Prosthesis -
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------HG MultiLock™ Hip Prosthesis With Ti-Nidium® Surface Hardening Process
- -MG II® Total Knee System with Ti-Nidium Surface Hardening Process
Image /page/0/Picture/22 description: The image shows a geometric pattern. The pattern is composed of six identical shapes arranged in a circular fashion around a central point. Each shape is a hexagon, and each hexagon is divided into six smaller triangles. The triangles are arranged in a way that creates a sense of radial symmetry.
1
Device Description
The design of the femoral heads includes a spherical head portion that is highly polished and processed with the Co-Nidium surface treatment. Femoral heads for total hip arthroplasty procedures are available in diameters from 22 to 32 mm with varying neck lengths. Femoral heads for hemi-hip arthroplasty procedures are available in 38 to 63 mm outer diameters. The femoral heads include a tapered portion that fits securely onto a modular femoral stem component.
-
Intended Use
Femoral heads are single-use devices that are mated via a press-fit tapered neck with titanium or cobalt-chrome alloy femoral stems in total and hemi-hip arthroplasty procedures. -
Performance Data
Wear testing demonstrated improved abrasive wear resistance when compared to the predicate device. Corrosion testing demonstrated that the breakdown potential of the alloy material is not changed by surface hardening. Fatigue testing indicated that the fatigue strength of the nitrided alloy is higher than the fatigue strength of currently marketed devices. Dimensional analysis and coefficient of friction data showed no change for the nitrided femoral heads. Microhardness and ESCA data exhibited higher hardness and depth of hardening when compared to the predicate device.
RA01651K.RP