(100 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a hip implant, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a Modular Acetabular Shell II, which is an implant for hip replacement surgery. While it addresses a medical condition, its primary function is to replace a damaged joint, not to provide therapy in the sense of treatment or rehabilitation.
No
The device description indicates that the Modular Acetabular Shell II is an implant used in hip replacement surgery, and its testing involves evaluating the integrity of its components and locking mechanism, not diagnosing a medical condition.
No
The device description clearly indicates it is a physical implant made of metal and polyethylene, intended for surgical implantation. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," but the device description clearly indicates it's an implantable medical device for hip replacement surgery.
- Device Description: The description details a physical implant (acetabular shell and insert) used in surgery.
- Anatomical Site: The device is used in the "Hip Joint," which is an anatomical location within the body, not a sample being tested in vitro.
- Intended User/Care Setting: The intended user is a "Surgeon," indicating a surgical procedure, not a laboratory test.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical implant used in the body during surgery.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The Modular Acetabular Shell II is a metal hemispherical shell manufactured from Ti-6A1-4V alloy and coated with Cancellous Structured Titanium™ (CSTi™). This device may be implanted with or without bone cement and will be used in conjunction with a snap-in acetabular insert manufactured from ultra-high molecular weight polyethylene (UHMWPe). In order to address various clinical situations, these inserts are available in standard, hooded and hooded protrusio designs.
The Modular Acetabular Shell II may be implanted in a solid configuration or in a screwhole configuration. The shell is provided with screwhole plugs which are sintered in place. The screwhole plugs can be removed intraoperatively before or after implantation if the surgeon opts to enhance fixation of the shell with bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Summary of Performance Studies
Testing was conducted which demonstrated that the integrity of the screwhole plug bonds was maintained under fatigue loading conditions. Additionally, the inside surface of the screwhole, upon removal of the plug, was shown to be comparable to the screwhole surfaces of currently marketed devices.
The integrity of the locking mechanism of the Modular Shell II was investigated by examining the attachment strength between the acetabular shell and acetabular insert. The strength of the locking mechanism compares favorably to other currently marketed devices.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Modular Acetabular Shell II.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| Date: | December 15, 1995 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Hip Joint Metal/Polymer/Metal Semi-constrained Porous- coated Uncemented Prosthesis, 21CFR 888.3358 |
| Common/Usual Name: | Acetabular shell |
| Trade/Proprietary Name: | Modular Acetabular Shell II |
PRODUCT DESCRIPTION/SUBSTANTIAL EQUIVALENCE
The Modular Acetabular Shell II is a metal hemispherical shell manufactured from Ti-6A1-4V alloy and coated with Cancellous Structured Titanium™ (CSTi™). This device may be implanted with or without bone cement and will be used in conjunction with a snap-in acetabular insert manufactured from ultra-high molecular weight polyethylene (UHMWPe). In order to address various clinical situations, these inserts are available in standard, hooded and hooded protrusio designs.
The Modular Acetabular Shell II may be implanted in a solid configuration or in a screwhole configuration. The shell is provided with screwhole plugs which are sintered in place. The screwhole plugs can be removed intraoperatively before or after implantation if the surgeon opts to enhance fixation of the shell with bone screws.
Testing was conducted which demonstrated that the integrity of the screwhole plug bonds was maintained under fatigue loading conditions. Additionally, the inside surface of the screwhole, upon removal of the plug, was shown to be comparable to the screwhole surfaces of currently marketed devices.
1
The integrity of the locking mechanism of the Modular Shell II was investigated by examining the attachment strength between the acetabular shell and acetabular insert. The strength of the locking mechanism compares favorably to other currently marketed devices.
The Modular Acetabular Shell II is substantially equivalent to the Option Shell (Intermedics Orthopedics, Inc.). Furthermore, the concept of providing the surgeon with an acetabular component which may be implanted in a solid configuration or in a screwhole configuration is substantially equivalent to the concept behind the Acetabular Dome and Screw Hole Plugs (Osteonics®). Additionally, with the screwhole plugs removed, the Modular Acetabular Shell U is substantially equivalent to the APR® Acetabular Shell (Intermedics Orthopedics, Inc.). In its solid configuration, the Modular Acetabular Shell II is substantially equivalent to the Non-Holed design of the Trilogy Acetabular System (Zimmer, Inc.).