MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM

K081747 · Synthes (Usa) · NEI · Sep 5, 2008 · Dental

Device Facts

• Record ID: K081747
• Device Name: MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
• Applicant: Synthes (Usa)
• Product Code: NEI · Dental
• Decision Date: Sep 5, 2008
• 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 Condylar Head Add-on System is an adjustable height reconstruction component for use with 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. Device consists of a condylar head, 2 screws, and one of four fixation plates with varying screw hole spacing to determine condylar head height. Used by surgeons in clinical settings for temporary mandibular reconstruction following ablative tumor surgery. Device provides structural support during the temporary phase; not intended for permanent implantation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Adjustable height condylar head system. Components include condylar head, screws, and fixation plates. Compatible with 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. Mechanical fixation via screw hole spacing.

Indications for Use

Indicated for temporary reconstruction in patients undergoing ablative tumor surgery requiring removal of the mandibular condyle. Contraindicated for permanent implantation, patients with TMJ, traumatic injuries, or temporomandibular joint disease (TMD).

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 (USA) Condylar Head Add-on-System

Submission Summary (Full Text)

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K081747

ISEP - 5 2008

| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sponsor: | Synthes (USA)<br>1301 Goshen parkway<br>West Chester, PA 19380<br>Contact: Andrea M. Tasker<br>[phone] |
| | Device Name: | Synthes (USA) Condylar Head Add-on-System - Modification |
| | Classification: | 21 CFR 872.3960: Mandibular condyle prosthesis |
| | Predicate Devices: | Synthes (USA) Condylar Head Add-on-System |
| | Device Description: | The Synthes Condylar Head Add-on System is an adjustable height<br>add-on system for use with the 2.4 mm Locking Reconstruction<br>Plate System and MatrixMANDIBLE Plate System. It consists of a<br>condylar head, 2 screws, and one of four (4) fixation plates, each<br>with a different screw hole spacing that determines the height of the<br>condylar head. |
| | 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 patients<br>with TMJ or traumatic injuries, or for treatment of<br>temporomandibular joint disease (TMD). |
| | Substantial Equivalence: | Documentation is provided which demonstrates the Synthes (USA)<br>Condylar Head Add-on-System - Modification to be substantially<br>equivalent to other legally marketed devices such as:<br>Synthes (USA) Condylar Head Add-on-System |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2008

Ms. Andrea M. Tasker Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K081747

Trade/Device Name: Synthes (USA) Condylar Head Add-on System Regulation Number: Unclassified Regulation Name: None Regulatory Class: II Product Code: NEI Dated: June 16, 2008 Received: June 19, 2008

Dear Ms. Tasker:

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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Page 2 - Ms. Tasker

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 (QS) 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 your 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,

JK Vammels-Lindner foreh

Chiu S. Lin. Ph. D Division 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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Page 1 of l

2.0 Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

Synthes (USA) Condylar Head Add-on System

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).

Prescription Use X (Per 21 CFR 801.109)

AND/OR

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

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Concurrence of CDRH, Offic içe Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K081247