OSTEONICS SCREW HOLE PLUGS

K965056 · Osteonics Corp. · JDK · Feb 28, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K965056
• Device Name: OSTEONICS SCREW HOLE PLUGS
• Applicant: Osteonics Corp.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Feb 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2

Intended Use

The Osteonics® Screw Hole Plugs are intended to occlude the unused dome screw holes of any Osteonics acetabular shell component. The Osteonics® Screw Hole Plugs will be used either with or without bone cement depending upon the labeled indications of the associated acetabular shell component. The Osteonics® Screw Hole Plugs do not carry their own indications and contraindications, but-- as accessories to acetabular shell components-- would be subject to all of the indications and contraindications of the associated acetabular shells.

Device Story

Small circular plugs; manufactured from low density polyethylene; designed to occlude unused acetabular dome screw holes in Osteonics acetabular shell components. Factory-assembled to shell; surgeon removes plugs intraoperatively from holes requiring bone screws. Function: prevent bone cement intrusion into shell and debris migration into acetabulum. Used in OR by orthopedic surgeons during hip arthroplasty. Non-load bearing; no contact with acetabular insert or host bone.

Clinical Evidence

Bench testing only. Laboratory testing performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading.

Technological Characteristics

Material: low density polyethylene. Form factor: small circular disks. Function: non-load bearing mechanical occlusion of acetabular screw holes. Pre-assembled to acetabular shell components.

Indications for Use

Indicated for use as accessories to Osteonics acetabular shell components to occlude unused dome screw holes. Patient population and contraindications are those of the associated acetabular shell component.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Osteonics® Omnifit® UHMWPE Acetabular Shell Cement Spacer System
• Osteonics® Acetabular Screw Hole Plugs
• Osteonics® Universal Cement Plug

Submission Summary (Full Text)

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FEB 28 1997
K965056

510(k) Premarket Notification
Summary of Safety and Effectiveness
for the
Osteonics® Screw Hole Plugs

## 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: | December 17, 1996 |

## Device Identification

| Proprietary Name: | Osteonics® Screw Hole Plugs |
| --- | --- |
| Common Name: | Prosthesis, hip, cement restrictor |
| Classification Name and Reference: | Surgical mesh
21 CFR §878.3300 |

## Predicate Device Identification

The Osteonics® Screw Hole Plugs are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

- Osteonics® Omnifit® UHMWPE Acetabular Shell Cement Spacer System,
- Osteonics® Acetabular Screw Hole Plugs,
- Osteonics® Universal Cement Plug

## Device Description

The Osteonics® Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene and which are intended to occlude all acetabular dome screw holes not occupied by bone screws. The Osteonics® Screw Hole Plugs will be factory-assembled to every

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acetabular dome screw hole in the acetabular shell. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw.

The Osteonics® Screw Hole Plugs, by occluding the shell screw holes, will help prevent intrusion of bone cement into the shell and potential migration of debris through open screw holes into the acetabulum.

## Intended Use:

The Osteonics® Screw Hole Plugs are intended to occlude the unused dome screw holes of any Osteonics acetabular shell component. The Osteonics® Screw Hole Plugs will be used either with or without bone cement depending upon the labeled indications of the associated acetabular shell component. The Osteonics® Screw Hole Plugs do not carry their own indications and contraindications, but-- as accessories to acetabular shell components-- would be subject to all of the indications and contraindications of the associated acetabular shells.

## Statement of Technological Comparison:

The substantial equivalence of the subject devices to the predicate devices, in terms of design, materials, and intended use are discussed below.

## Design:

The subject Osteonics® Screw Hole Plugs and the predicate Osteonics® Acetabular Screw Hole Plugs are both circular disks intended to occlude unused screw holes. The subject devices are pre-assembled to their shells at Osteonics, and may be removed by the surgeon intraoperatively. The predicate devices were not pre-assembled, but instead were assembled to their shells intraoperatively.

## Materials

The subject devices are made from low density polyethylene. The predicate cement plug is made from the same low density polyethylene as the subject device. The subject devices have been designed so that they contact neither the acetabular insert nor the acetabular host bone. Because the subject devices are non-load bearing, low density polyethylene is an appropriate material for this application.

## Intended Use:

Both the subject Osteonics® Screw Hole Plugs and the predicate Osteonics® Acetabular Screw Hole Plugs are intended to occlude unused screw holes, thus preventing potential intrusion of bone cement and potential emigration of debris through the shell screw holes into the acetabulum. Both the subject and predicate devices are intended for cemented or cementless applications, depending upon the intended use of the associated acetabular shell.

## Performance Data:

Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading.

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