OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)

K963946 · Osteonics Corp. · LPH · Jan 27, 1997 · Orthopedic

Device Facts

• Record ID: K963946
• Device Name: OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
• Applicant: Osteonics Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Jan 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® Modular Acetabular Cup components are single-use devices. The polyethylene insert is intended for cemented assembly to the metal shell. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Modular Acetabular Cup is compatible with any appropriately selected Osteonics hip stem/femoral head combination. In addition, the Osteonics® ABC Cementable Polyethylene Insert - because its assembly method is independent of the inner geometry of the mating shell - is compatible with any commercially-available Osteonics metal acetabular shell component.

Device Story

Modular acetabular cup system consisting of metal shell and cementable polyethylene insert. Metal shell (ASTM F-67 CP Titanium with porous coating) implanted into acetabulum via cement or cementless fixation. Polyethylene insert (UHMWPE) secured to shell using bone cement. Insert features machined grooves and roughened outer surface to enhance cement interdigitation. Used by orthopedic surgeons in clinical settings for hip arthroplasty. Device provides artificial bearing surface for hip joint; restores joint function; alleviates pain associated with degenerative or traumatic hip disease. Compatible with existing Osteonics hip stems and femoral heads.

Clinical Evidence

Bench testing only. Laboratory testing characterized push-out strength of the shell/insert assembly. Results demonstrated that the assembly method is comparable to predicate shell/insert assembly methods.

Technological Characteristics

Materials: ASTM F-67 CP Titanium (shell), UHMWPE (insert). Design: Modular acetabular cup; shell features beaded porous coating; insert features machined-in grooves and roughened outer surface for cement interdigitation. Bearing thickness ≥6mm. Available in various diameters and 0°, 10°, or 20° hooded face versions. Single-use.

Indications for Use

Indicated for patients with painful, disabling hip joint disease due to degenerative, rheumatoid, or post-traumatic arthritis, or late-stage avascular necrosis; revision of failed femoral head replacement, cup arthroplasty, or other procedures; clinical management where arthrodesis or alternative reconstruction is less likely to succeed; or cases with poor bone stock/acetabular deficiencies.

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

• Osteonics® Omnifit® PSL® MicroStructured® Shells
• Osteonics® Restoration GAP Acetabular Cups
• Osteonics® Omnifit® Cup Inserts

Reference Devices

• Osteonics® Omnifit® Cup Inserts (Series II)

Submission Summary (Full Text)

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JAN 27 1997
Osteonics® Modular Acetabular Cup (MicroStructured® Version)
510(k) Summary

# 510(k) Premarket Notification
## Summary of Safety and Effectiveness for the
## Osteonics® Modular Acetabular Cup
## (MicroStructured® Version)

**K963946**

### Submission Information

| Name and Address of the Sponsor of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
| --- | --- |
| Contact Person: | Terry Sheridan
Regulatory Affairs Specialist |
| Date of Summary Preparation: | October 1, 1996 |

### Device Identification

| Proprietary Name: | Osteonics® Modular Acetabular Cup |
| --- | --- |
| Common Name: | Artificial Acetabular Component |
| Classification Name and Reference: | Hip Joint Metal/Polymer/Metal Semi-Constrained, Porous Coated, Uncemented Prosthesis
21 CFR §888.3358 |

### Predicate Device Identification

The Osteonics® Modular Acetabular Cup components are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

- Osteonics® Omnifit® PSL® MicroStructured® Shells: Osteonics Corporation.
- Osteonics® Restoration GAP Acetabular Cups: Osteonics Corporation.
- Osteonics® Omnifit® Cup Inserts: Osteonics Corporation.

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Osteonics® Modular Acetabular Cup (MicroStructured® Version)
510(k) Summary

## Device Description

The Osteonics® Modular Acetabular Cup components are single-use devices. Each Osteonics® Modular Acetabular Cup consists of two pieces: an Osteonics® PSL® MicroStructured® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The polyethylene insert is intended for cemented assembly to the metal shell.

## Intended Use:

The Osteonics® Modular Acetabular Cup components are single-use devices. The polyethylene insert is intended for cemented assembly to the metal shell. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Modular Acetabular Cup is compatible with any appropriately selected Osteonics hip stem/femoral head combination. In addition, the Osteonics® ABC Cementable Polyethylene Insert - because its assembly method is independent of the inner geometry of the mating shell - is compatible with any commercially-available Osteonics metal acetabular shell component.

## Indications:

The indications for the use of the Osteonics® Modular Acetabular Cup, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

## Statement of Technological Comparison:

The substantial equivalence of the Osteonics® Modular Acetabular Cup System components to the predicate devices identified above - in terms of materials, intended uses, and design features - is based on the following.

## Materials:

**Osteonics® PSL® MicroStructured® ABC Shells**

The Osteonics® PSL® MicroStructured® ABC Shells, like the predicate Osteonics® Omnifit® PSL® MicroStructured® Shells are manufactured from ASTM F-67 Commercially Pure Titanium, and feature a beaded, porous coating of ASTM F-67 CP Titanium beads.

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Osteonics® Modular Acetabular Cup (MicroStructured® Version)
510(k) Summary

# Osteonics® ABC Cementable Polyethylene Inserts

The mating Osteonics® ABC Cementable Polyethylene Inserts, like the predicate Osteonics® Omnifit® Cup Inserts (Series II), are manufactured from UHMWPE.

# Intended Use:

## Osteonics® PSL® MicroStructured® ABC Shells

The subject Osteonics® PSL® MicroStructured® ABC Shells and the predicate Osteonics® Omnifit® PSL® MicroStructured® Shells share the same indications for use, and both shells are intended for cemented or cementless fixation within the prepared acetabulum.

## Osteonics® ABC Cementable Polyethylene Inserts

The subject Osteonics® ABC Cementable Polyethylene Inserts and the predicate Osteonics® Omnifit® Cup Inserts share the same indications for use. The Osteonics® ABC Cementable Polyethylene Inserts are intended for cemented assembly to their mating shells. This assembly method is predicated by the commercially available Osteonics® Omnifit® Cup Inserts (Series II), which have been determined substantially equivalent for cemented assembly to the commercially available Osteonics® Restoration GAP Acetabular Shells.

# Design:

## Osteonics® PSL® MicroStructured® ABC Shells

The subject Osteonics® PSL® MicroStructured® ABC Shells differ most notably from the commercially available Osteonics® Omnifit® PSL® MicroStructured® Shells with regard to their interior geometries. The subject device has a tapered interior geometry, and is intended to receive a cementable polyethylene insert.

Both the subject Osteonics® PSL® MicroStructured® ABC Shells and the predicate Osteonics® Omnifit® PSL® MicroStructured® Acetabular Shells are manufactured from the same materials, feature the same basic shape, and feature the same Osteonics® MicroStructured® coating.

## Osteonics® ABC Cementable Polyethylene Inserts

The Osteonics® ABC Cementable Polyethylene Inserts have several features which make them relatively more amenable to the cemented assembly method than their predicate inserts. These features include:

- Machined-in grooves: These grooves allow interdigitation with the bone cement.
- Roughened outer/back surface: The back/outer surface of the insert has been roughened to provide a stronger insert/cement interface than would be characteristic of a smoother polyethylene surface.

Neither the machined-in grooves, nor the roughened finish of the outer surface raise any new questions with regard to safety or effectiveness; both of these features are routinely employed in commercially available, one-piece, all-polyethylene acetabular cup designs.

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Osteonics® Modular Acetabular Cup (MicroStructured® Version)
510(k) Summary

Both the subject Osteonics® ABC Cementable Polyethylene Inserts and the predicate Osteonics® Omnifit® Cup Inserts (Series II) maintain a bearing area polyethylene thickness which is ≥6mm. Both the subject and the predicate inserts come in a wide range of inner diameter and outer diameter sizes. Both the subject and the predicate inserts come in versions with a 0°, 10°, or 20° hooded face.

## Performance Data:

Laboratory testing was undertaken to characterize the push-out strength of the Osteonics® ABC Cementable Polyethylene Inserts when assembled to their mating acetabular shells. The test results demonstrate that the shell/insert assembly method for the Osteonics® Modular Acetabular Cup components is comparable in terms of push-out strength to predicate shell/insert assembly methods and mechanisms.

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