MODULAR ACETABULAR SHELL II

K955739 · Intermedics Orthopedics · LPH · Mar 27, 1996 · Orthopedic

Device Facts

• Record ID: K955739
• Device Name: MODULAR ACETABULAR SHELL II
• Applicant: Intermedics Orthopedics
• Product Code: LPH · Orthopedic
• Decision Date: Mar 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Modular Acetabular Shell II; hemispherical metal shell; Ti-6Al-4V alloy; Cancellous Structured Titanium (CSTi) coating. Used with snap-in UHMWPe acetabular inserts (standard, hooded, hooded protrusio). Implanted with or without bone cement. Features solid or screwhole configurations; removable sintered screwhole plugs allow intraoperative screw fixation. Surgeon-operated; used in orthopedic hip arthroplasty. Provides stable acetabular component fixation; locking mechanism secures insert to shell. Benefits patient via modularity and fixation options.

Clinical Evidence

Bench testing only. Integrity of screwhole plug bonds verified under fatigue loading. Locking mechanism attachment strength compared to predicate devices.

Technological Characteristics

Material: Ti-6Al-4V alloy with Cancellous Structured Titanium (CSTi) coating; UHMWPe inserts. Design: Hemispherical shell, modular, solid or screwhole configuration. Fixation: Uncemented or cemented. Mechanical locking mechanism for inserts.

Indications for Use

Indicated for patients requiring hip joint replacement using a semi-constrained porous-coated uncemented prosthesis.

Regulatory Classification

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.

Predicate Devices

• Option Shell (Intermedics Orthopedics, Inc.)
• Acetabular Dome and Screw Hole Plugs (Osteonics)
• APR Acetabular Shell (Intermedics Orthopedics, Inc.)
• Trilogy Acetabular System (Zimmer, Inc.)

Submission Summary (Full Text)

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K955739

# 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
[phone] | MAR 27 |
| --- | --- | --- |
| 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-6Al-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 Acetabular 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 II 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.).