OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS

K970779 · Osteonics Corp. · LZN · May 9, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970779
• Device Name: OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
• Applicant: Osteonics Corp.
• Product Code: LZN · General, Plastic Surgery
• Decision Date: May 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2

Intended Use

The Osteonics® Tibial Tray Screw Hole Plugs are intended to occlude the unused tibial screw holes of any Osteonics tibial tray component. The Osteonics® Tibial Tray Screw Hole Plugs will be used with bone cement. The Osteonics® Tibial Tray Screw Hole Plugs do not carry their own indications and contraindications, but-- as accessories to tibial tray components-- would be subject to all of the indications and contraindications of the associated tibial trays.

Device Story

Small circular plugs; manufactured from low density polyethylene (LDPE); pre-assembled into tibial tray screw holes at factory. Intraoperatively, surgeon removes plugs from holes requiring bone screws; remaining plugs occlude unused holes. Prevents bone cement intrusion onto tibial tray surface. Used in cemented knee arthroplasty; non-load bearing application.

Clinical Evidence

Bench testing only; laboratory testing performed to evaluate performance under simulated physiological loading.

Technological Characteristics

Material: Low density polyethylene (LDPE). Form factor: Small circular disks. Function: Non-load bearing occlusion of tibial tray screw holes. Application: Cemented knee arthroplasty.

Indications for Use

Indicated for use as accessories to Osteonics tibial tray components in cemented knee arthroplasty procedures to occlude unused screw holes and prevent bone cement intrusion.

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® Total Knee System Screw Hole Plugs
• Osteonics® Universal Cement Plug

Submission Summary (Full Text)

{0}

MAY - 9 1997
K970779

# 510(k) Premarket Notification
## Summary of Safety and Effectiveness for the Osteonics® Tibial Tray 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: | Kate Sutton
Regulatory Affairs Specialist |
| Date of Summary Preparation: | March 3, 1997 |

### Device Identification

| Proprietary Name: | Osteonics® Tibial Tray Screw Hole Plugs |
| --- | --- |
| Common Name: | Tibial tray screw hole plugs |
| Classification Name and Reference: | Surgical mesh
21 CFR §878.3300 |

### Predicate Device Identification

The Osteonics® Tibial Tray 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® Total Knee System Screw Hole Plugs
- Osteonics® Universal Cement Plug

### Device Description

The Osteonics® Tibial Tray Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene (LDPE) and which are intended to occlude all tibial tray screw holes not occupied by bone screws. The Osteonics® Tibial Tray Screw Hole Plugs will be

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factory-assembled into every tibial tray hole. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw.

The Osteonics® Tibial Tray Screw Hole Plugs, by occluding the tibial tray screw holes, will help prevent intrusion of bone cement onto the surface of the tibial tray.

## Intended Use:

The Osteonics® Tibial Tray Screw Hole Plugs are intended to occlude the unused tibial screw holes of any Osteonics tibial tray component. The Osteonics® Tibial Tray Screw Hole Plugs will be used with bone cement. The Osteonics® Tibial Tray Screw Hole Plugs do not carry their own indications and contraindications, but-- as accessories to tibial tray components-- would be subject to all of the indications and contraindications of the associated tibial trays.

## 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® Tibial Tray Screw Hole Plugs and the UHMWPE screw hole plugs discussed in the predicate 510(k) are both circular disks intended to occlude unused screw holes. The subject devices are pre-assembled to their tibial trays at Osteonics, and may be removed by the surgeon intraoperatively.

## Materials

The subject devices are made from low density polyethylene (LDPE). This material was chosen for its successful clinically demonstrated history of use, as well as its ability to be injection molded. The predicate cement plug is made from the same low density polyethylene as the subject device. Because the subject devices are non-load bearing, low density polyethylene is an appropriate material for this application.

## Intended Use:

Both the subject Osteonics® Tibial Tray Screw Hole Plugs and the UHMWPE tibial tray screw hole plugs of the predicate Omnifit® Total Knee System are intended to occlude unused screw holes, thus preventing potential intrusion of bone cement.

The subject and predicate devices are intended for cemented applications only.

## 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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