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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.
This document is a 510(k) summary for a medical device (Modular Acetabular Shell II) and does not contain the type of acceptance criteria and study information typically associated with AI/ML-based medical devices.
The provided text focuses on the mechanical and material properties of a hip implant device, and its substantial equivalence to other existing devices based on these properties. It describes physical testing related to:
- Integrity of screwhole plug bonds under fatigue loading.
- Comparability of screwhole surfaces to marketed devices.
- Attachment strength between the acetabular shell and insert.
Therefore, I cannot provide a response filling out the requested table and sections, as the input document does not pertain to the performance evaluation of an AI/ML device in the context of diagnostic accuracy, which is what your questions are designed to cover.
To reiterate, the input discusses:
- Device Type: A hip joint prosthetic (acetabular shell).
- Evaluation Method: Mechanical testing and comparison to predicate devices, not clinical studies involving human readers or AI algorithms for diagnostic tasks.
- Performance Metrics: Durability, bond integrity, attachment strength – not sensitivity, specificity, AUC, etc.
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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 DriveAustin, Texas 78717(512) 432-9900 |
|---|---|
| Date: | December 15, 1995 |
| Contact Person: | Jacquelyn HughesManager, 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.
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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.).
§ 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.