SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM

K063181 · Synthes (Usa) · NEI · Jan 5, 2007 · Dental

Device Facts

• Record ID: K063181
• Device Name: SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
• Applicant: Synthes (Usa)
• Product Code: NEI · Dental
• Decision Date: Jan 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

Device Story

Synthes (USA) Condylar Head Add-on System is an adjustable-height prosthetic component designed for use with the 2.4 mm Locking Reconstruction Plate (LRP) System. The device consists of an elliptical condylar head, four fixation plates for height adjustment, and two fixation screws. It is intended for temporary use in patients undergoing ablative tumor surgery involving mandibular condyle removal. The system is installed by a surgeon during the reconstructive procedure to restore mandibular structure following tumor resection. It is not intended for permanent implantation or treatment of TMJ/TMD conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises an elliptical condylar head, four height-adjustable fixation plates, and two fixation screws. Designed for integration with 2.4 mm Locking Reconstruction Plate (LRP) systems. Mechanical assembly; no software or electronic components.

Indications for Use

Indicated for temporary mandibular condyle reconstruction in patients undergoing ablative tumor surgery. Contraindicated for permanent implantation, TMJ patients, traumatic injury patients, and TMD treatment.

Regulatory Classification

Identification

A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.

Special Controls

*Classification.* Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.

Predicate Devices

• Synthes Locking Reconstruction Plate (LRP) with Condylar Head (K990637)
• Stryker Leibinger, Attachable Condylar Head (K020199)

Submission Summary (Full Text)

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3.0

K063/81

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| 510(k) Summary | Page <span style="text-decoration:underline;">1</span> of <span style="text-decoration:underline;">1</span> |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Synthes (USA) Condylar Head Add-on System<br>JAN - 5 2007 |
| Classification: | 21 CFR 872.3960: Mandibular condyle prosthesis |
| Predicate Devices: | Synthes Locking Reconstruction Plate (LRP) with Condylar Head<br>(K990637)<br>Stryker Leibinger, Attachable Condylar Head (K020199) |
| Device Description: | The Synthes (USA) Condylar Head Add-on System is an adjustable<br>height system intended for use with Synthes' 2.4 mm Locking<br>Reconstruction Plate (LRP) System. The system consists of an<br>elliptical shaped condylar head, four different fixation plates which<br>allow the surgeon to adjust the height of the condylar head, and<br>two fixation screws for mounting the condylar head and fixation<br>plate onto a 2.4 mm locking reconstruction plate. |
| Intended Use: | Intended for temporary reconstruction in patients undergoing<br>ablative tumor surgery requiring the removal of the mandibular<br>condyle. This device is not for permanent implantation, for<br>patients with TMJ or traumatic injuries, or for treatment of<br>temporomandibular joint disease (TMD). |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

SEP 9-2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Deborah L. Jackson Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K063181

Trade/Device Name: Synthes (USA) Condylar Head Add-on System Regulation Number: 872.3960 Regulation Name: Mandibular Condyle Prosthesis Regulatory Class: III Product Code: NEI Dated: October 18, 2006 Received: October 19, 2006

Dear Ms. Jackson:

This letter corrects our substantially equivalent letter of January 5, 2007.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

JAhmuels Jenkins for

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0 Indications for Use

510(k) Number (if known):

长063181

Device Name:

Synthes (USA) Condylar Head Add-on System

Indications for Use:

Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular This device is not for permanent implantation, for condyle. patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

X Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Susan Runne
(Division Sign-Off)

ision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K060318