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Meeting of the Dental Products Panel

August 22, 2002

Gaithersburg Holiday Inn

Gaithersburg, Maryland

**Thursday, August 22, 2002**

8:00 - 8:10 a.m. Welcome and Introductory Remarks

Dr. Leslie Heffez, Chair

Ms. Pamela Scott, Executive Secretary

8:15- 8:45 a.m. Open Public Hearing[^1]

> ***Issue:* Review of a Premarket Approval Application**
>
> *Sponsor:* **Biomet, Incorporated**
>
> *Product:* Walter Lorenz Total Temporomandibular Joint Replacement
> System

8:45-- 9:45 a.m. Industry Presentation

9:45 - 10:00 am Questions from the Panel for the Sponsor

10:00 - 10:30 a.m. FDA Presentations

Ms. Angela Blackwell, Biomedical Engineer, Dental Devices Branch

Dr. Kevin Mulry, Dental Officer, Dental Devices Branch

10:30 - 10:45 a.m. Questions from the Panel for FDA

10:45 -- 11:00 a.m. **BREAK**

11:00 -- noon Open Committee Discussion^\*^[^2]

12:00 - 1:30 p.m. **LUNCH**

1:30 -- 2:30 p.m. Open Committee Discussion

2:30 - 3:00 p.m. Open Public Hearing

3:00 -- 4:00 p.m. Open Committee Discussion and Vote

4:00 -- 4:15 p.m. Closing comments

Dr. Leslie Heffez

Ms. Pamela D. Scott

4:15 p.m. Meeting Adjourned

***ISSUE:** REVIEW OF PREMARKET APPROVAL APPLICATION*

***SPONSOR:** BIOMET, INCORPORATED*

***PRODUCT:** Walter Lorenz Total Temporomandibular Joint Replacement
System*

**BACKGROUND**

The Walter Lorenz Total Temporomandibular Joint Replacement System is
implanted in the jaw to functionally reconstruct a diseased and/or
damaged temporomandibular joint. The Total TMJ Replacement System is a
two component system comprised of mandibular condyle and glenoid fossa
components. Both components are available in multiple sizes as right and
left side specific designs and are attached to the bone by screws. The
final device system as presented in this PMA submission includes two
glenoid fossa designs, both available in small, medium, and large sizes.
One design of the glenoid fossa has a post for cement use; the other
design does not have a post. The mandibular component of the final
system includes a narrow design, standard design, and an offset design
(the offset design is also available in narrow and standard widths). The
narrow and offset mandibular components are available in lengths ranging
from 40 to 60 mm in 5 mm increments and the standard design is available
in lengths of 45 mm, 50 mm, and 55 mm.

## PANEL ACTIONS

The Panel is asked to provide a recommendation to the FDA on the above
premarket approval application (PMA). The PMA must stand on its own
merits and your recommendation must be supported by safety and
effectiveness data in the application. Safety is defined as reasonable
assurance, based on valid scientific evidence, that the probable
benefits to health (under conditions of use) outweigh any probable risks
\[21CFR 860.7(d)(1)\]. Effectiveness is defined as reasonable assurance
that, in a significant portion of the population, the use of the device
for its intended uses and conditions of use (when labeled) will provide
clinically significant results \[21 CFR 860.7(e)(1)\]. The Panel's
recommendation options for the vote are as follows: approval, approvable
with conditions and not approvable.

### 

###  

### DRAFT ROSTER

**DENTAL PRODUCTS PANEL MEETING**

+-----------------------------------+-----------------------------------+
| **[CHAIR]{.underline}**           | **[EXECUTIVE                      |
|                                   | SECRETARY]{.underline}**          |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
| **Dr. Leslie Heffez**             | **Ms. Pamela D. Scott**           |
+-----------------------------------+-----------------------------------+
| Professor and Department Head of  | Biomedical Engineer, Dental       |
| Oral and                          | Devices Branch                    |
+-----------------------------------+-----------------------------------+
| Maxillofacial Surgery             | #### Food and Drug Administration |
+-----------------------------------+-----------------------------------+
| University of Illinois, Chicago   | Center for Devices and            |
|                                   | Radiological Health               |
+-----------------------------------+-----------------------------------+
| Chicago, Illinois                 | Office of Device Evaluation       |
+-----------------------------------+-----------------------------------+
|                                   | Division of Anesthesiology,       |
|                                   | General Hospital,                 |
+-----------------------------------+-----------------------------------+
|                                   | Infection Control, and Dental     |
|                                   | Devices                           |
+-----------------------------------+-----------------------------------+

+---------------------------------+------------------------------------+
| **VOTING PANEL MEMBERS**        |                                    |
+---------------------------------+------------------------------------+
| **Dr. Kristi Anseth**           | **Dr. David Cochran**              |
|                                 |                                    |
| Patten Associate Professor      | Professor and Chairman             |
|                                 |                                    |
| Department of Chemical          | Department of Periodontics         |
| Engineering                     |                                    |
|                                 | University of Texas                |
| University of Colorado          |                                    |
|                                 | Health Science Center at San       |
| Boulder, Colorado               | Antonio                            |
|                                 |                                    |
|                                 | San Antonio, Texas                 |
+---------------------------------+------------------------------------+
| **Dr. Edmond Hewlett**          | **Dr. Diane Rekow**                |
|                                 |                                    |
| Associate Professor             | Director of Translational Research |
|                                 | and                                |
| Division of Cariology &         |                                    |
| Restorative                     | Professor of Orthodontics          |
|                                 |                                    |
| Dentistry                       | New York University College of     |
|                                 | Dentistry                          |
| University of California at Los |                                    |
| Angeles                         | New York, New York                 |
|                                 |                                    |
| School of Dentistry             |                                    |
|                                 |                                    |
| Los Angeles, California         |                                    |
+---------------------------------+------------------------------------+
| **Dr. Jon Suzuki**              |                                    |
|                                 |                                    |
| Professor                       |                                    |
|                                 |                                    |
| School of Dental Medicine       |                                    |
|                                 |                                    |
| University of Pittsburgh        |                                    |
|                                 |                                    |
| Pittsburgh, Pennsylvania        |                                    |
+---------------------------------+------------------------------------+
| **CONSUMER REPRESENTATIVE**     | **INDUSTRY REPRESENTATIVE**        |
+---------------------------------+------------------------------------+
| **Ms. Elizabeth Howe**          | **Mr. Daniel Schechter**           |
|                                 |                                    |
| Outreach Coordinator            | General Counsel                    |
|                                 |                                    |
| National Foundation for         | Parkell, Inc.                      |
| Ectodermal                      |                                    |
|                                 | Farmingdale, New York              |
| Dysplasias                      |                                    |
|                                 |                                    |
| Auburn, Washington              |                                    |
+---------------------------------+------------------------------------+

**DRAFT ROSTER (CONTINUED)**

+-----------------------------------+-----------------------------------+
| **PATIENT REPRESENTATIVE**        |                                   |
+-----------------------------------+-----------------------------------+
| **Ms. Elizabeth Helms**           |                                   |
|                                   |                                   |
| President                         |                                   |
|                                   |                                   |
| TMJ Society of California         |                                   |
|                                   |                                   |
| Sacramento, California            |                                   |
+-----------------------------------+-----------------------------------+
| **PANEL CONSULTANTS**             |                                   |
+-----------------------------------+-----------------------------------+
| **Dr. Peter Bertrand**            | **Dr. Richard Burton**            |
|                                   |                                   |
| Director, Orofacial Pain Clinic   | Assistant Professor of Oral and   |
|                                   | Maxillofacial Surgery             |
| Specialty Advisor for Oral Facial |                                   |
| Pain and                          | Department of Hospital Dentistry  |
|                                   |                                   |
| TMD                               | University of Iowa Hospitals and  |
|                                   | Clinics                           |
| National Naval Medical Center     |                                   |
|                                   | Iowa City, Iowa                   |
| Bethesda, Maryland                |                                   |
+-----------------------------------+-----------------------------------+
| **Dr. Janine Janosky**            | **Dr. Stephen Li**                |
|                                   |                                   |
| Associate Professor               | President                         |
|                                   |                                   |
| Division of Biostatistics         | Medical Device Testing and        |
|                                   | Innovations                       |
| University of Pittsburg           |                                   |
|                                   |                                   |
| Dept. of Family Medicine and      |                                   |
| Clinical Epidemiology             |                                   |
|                                   |                                   |
| Pittsburgh, Pennsylvania 15261    |                                   |
+-----------------------------------+-----------------------------------+
| **Dr. Mark R. Patters**           | **Dr. Jan Faulk-Eggleston**       |
|                                   |                                   |
| Chair                             | Chief                             |
|                                   |                                   |
| Department of Periodontology      | Oral and Maxillofacial Surgery    |
|                                   | Service                           |
| College of Dentistry              |                                   |
|                                   | Brooke Army Medical Center        |
| University of Tennessee           |                                   |
|                                   | Fort Sam Houston, Texas           |
| Memphis, Tennessee                |                                   |
+-----------------------------------+-----------------------------------+

+-----------------------------------+-----------------------------------+
| **FDA PARTICIPANTS**              |                                   |
+-----------------------------------+-----------------------------------+
| **Dr. Susan Runner**              | **Dr. Kevin Mulry**               |
|                                   |                                   |
| Branch Chief, Dental Devices      | Dental Officer, Dental Devices    |
| Branch                            | Branch                            |
|                                   |                                   |
| Division of Anesthesiology,       | Division of Anesthesiology,       |
| General Hospital, Infection       | General Hospital, Infection       |
| Control and Dental Devices        | Control and Dental Devices        |
|                                   |                                   |
| ODE/CDRH/FDA                      | ODE/CDRH/FDA                      |
+-----------------------------------+-----------------------------------+
| **Ms. Angela Blackwell**          | **Ms. Phyllis Silverman**         |
|                                   |                                   |
| Biomedical Engineer, Dental       | Biomedical Statistician           |
| Devices Branch                    |                                   |
|                                   | Division of Biostatistics         |
| Division of Anesthesiology,       |                                   |
| General Hospital, Infection       | OSB/CDRH/FDA                      |
| Control and Dental Devices        |                                   |
|                                   |                                   |
| ODE/CDRH/FDA                      |                                   |
+-----------------------------------+-----------------------------------+

[^1]: \*Near the end of committee deliberations, a 30-minute open public
    session will be conducted for interested persons to address issues
    specific to the classification before the committee.

[^2]: \*^\*^Open Committee Discussion: This portion of the meeting is
    open to public observers. Public attendees may not participate
    except at the specific request of the panel chairperson and the FDA
    executive secretary.