OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)

K963959 · Osteonics Corp. · MEH · Dec 19, 1996 · Orthopedic

Device Facts

• Record ID: K963959
• Device Name: OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
• Applicant: Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Dec 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® Secur-Fit™-HA PSL® ABC Shell is intended for cementless fixation within the prepared acetabulum. Osteonics® ABC Cementable Polyethylene Insert is intended for cemented assembly to the metal shell. 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 CP Titanium shell with hydroxylapatite coating and UHMWPE insert. Shell intended for cementless fixation; insert intended for cemented assembly into shell. Used in orthopedic hip arthroplasty procedures. Surgeon selects components based on patient anatomy. Insert features machined grooves and roughened outer surface to enhance interdigitation with bone cement. System provides bearing surface for hip joint reconstruction, aiming to restore joint function and alleviate pain in patients with degenerative or traumatic hip disease.

Clinical Evidence

Bench testing only. Laboratory testing characterized push-out strength of the shell/insert assembly, demonstrating performance comparable to predicate assembly methods.

Technological Characteristics

Modular acetabular prosthesis. Shell: CP Titanium with arc-deposited CP Titanium and plasma-sprayed hydroxylapatite coating. Insert: UHMWPE. Features machined-in grooves and roughened outer surface for cement interdigitation. Available in various diameters with 0°, 10°, or 20° hooded face options. Bearing thickness ≥ 6mm.

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 unsuccessful femoral head replacement, cup arthroplasty, or other procedures; clinical management where arthrodesis or alternative reconstruction is less likely to succeed; or cases with poor/inadequate acetabular bone stock.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Osteonics® Secur-Fit™-HA PSL® Shells
• Osteonics® Restoration GAP Acetabular Cups
• Osteonics® Omnifit® Cup Inserts

Submission Summary (Full Text)

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Osteonics® Modular Acetabular Cup (HA-Coated Version)
510(k) Summary

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

**K963959**

## Submission Information

**DEC 19 1996**

| 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/Ceramic/Polymer,
Semi-Constrained, Cemented or
Non-porous Uncemented Prosthesis
21 CFR §888.3353 |

## 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® Secur-Fit™-HA PSL® Shells: Osteonics Corporation.
- Osteonics® Restoration GAP Acetabular Cups: Osteonics Corporation.
- Osteonics® Omnifit® Cup Inserts: Osteonics Corporation.

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Osteonics® Modular Acetabular Cup (HA-Coated 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® Secur-Fit™-HA PSL® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert.

# Intended Use:

The Osteonics® Secur-Fit™-HA PSL® ABC Shell is intended for cementless fixation within the prepared acetabulum. Osteonics® ABC Cementable Polyethylene Insert is intended for cemented assembly to the metal shell. 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 components to the predicate devices identified above - in terms of materials, intended uses, and design features - is based on the following.

# Materials:

**Osteonics® Secur-Fit™-HA PSL® ABC Shells**

The Osteonics® Secur-Fit™-HA PSL® ABC Shells, like the predicate Osteonics® Secur-Fit™-HA PSL® Shells, are manufactured from CP Titanium, and feature an outer coating of arc-deposited CP Titanium and a plasma-sprayed coating of hydroxylapatite.

**Osteonics® Cementable Polyethylene Inserts**

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

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Osteonics® Modular Acetabular Cup (HA-Coated Version)
510(k) Summary

## Intended Use:

### Osteonics® Secur-Fit™-HA PSL® ABC Shells

The subject Osteonics® Secur-Fit™-HA PSL® ABC Shells and the predicate Osteonics® Secur-Fit™-HA PSL® ABC Shells share the same indications for use, and both shells are intended for cementless fixation within the prepared acetabulum.

### Osteonics® Cementable Polyethylene Inserts

The 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® Secur-Fit™-HA PSL® ABC Shells

The subject Osteonics® Secur-Fit™-HA PSL® ABC Shell differs most notable from the commercially available Osteonics® Secur-Fit™-HA PSL® Shell with regard to its interior geometry. The subject device has a tapered interior geometry, and is intended to receive a cementable polyethylene insert.

Both the subject Osteonics® Secur-Fit™-HA PSL® ABC Shells and the predicate Osteonics® Secur-Fit™-HA PSL® Shells are manufactured from the same materials, feature the same basic shape, and feature the same Osteonics’ AD-HA 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.

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 $\geq 6\mathrm{mm}$. Both the subject and the predicate inserts come in a wide range of inner diameter and outer

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Osteonics® Modular Acetabular Cup (HA-Coated Version)
510(k) Summary

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® 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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