SONICWELD RX ENDOBROW FIXATION

K061507 · KLS-Martin L.P. · JEY · Sep 21, 2006 · Dental

Device Facts

• Record ID: K061507
• Device Name: SONICWELD RX ENDOBROW FIXATION
• Applicant: KLS-Martin L.P.
• Product Code: JEY · Dental
• Decision Date: Sep 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SonicWeld Rx Endobrow Fixation will be used to support non-load bearing tissues of the craniofacial skeleton, including but not limited to endobrow fixation.

Device Story

SonicWeld Rx Endobrow Fixation is a bone plate system designed for craniofacial fixation. The device supports non-load bearing tissues. It is intended for use by clinicians in a surgical setting. The system functions as a mechanical fixation device to stabilize tissues during the healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bone plate system for craniofacial fixation. Materials are resorbable polymers consistent with predicate devices. Mechanical fixation principle.

Indications for Use

Indicated for support of non-load bearing tissues of the craniofacial skeleton, including endobrow fixation.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Resorb-X SF (K051236)
• The Bioplate Resorbable Endobrow Fixation System (K051845)
• LactoSorb Craniofacial Anchor-Push Screw (K013557)

Submission Summary (Full Text)

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KUS SERVER L.P.

SEP 2 1 2006

## SonicWeld Rx Endobrow Fixation

510(k) Summary

| Submitter: | KLS-Martin, L.P.<br>11239-1 St. Johns Industrial Parkway South<br>Jacksonville, FL 32246<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato<br>Director RA/QA |
| Date of Summary: | 19 May 2006 |
| Device Name: | SonicWeld Rx Endobrow Fixation |
| Trade Name: | SonicWeld Rx Endobrow Fixation |
| Common Name: | Bone Plate |
| Classification<br>Name and Number: | Bone plate (CFR 872.4760) |
| Regulatory Class: | II |
| Predicate Devices: | Resorb-X SF (K051236) |
| Predicate Devices: | The Bioplate Resorbable Endobrow Fixation<br>System (K051845) |
| Predicate Devices: | LactoSorb Craniofacial Anchor-Push Screw<br>(K013557) |
| Intended Use: | The SonicWeld Rx Endobrow Fixation will be<br>used to support non-load bearing tissues of the<br>craniofacial skeleton, including but not limited<br>to endobrow fixation |

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 1 2006

Ms. Jennifer Damato Director RA/QA KLS-Martin, L.P. 11239 St. Johns Industrial, Parkway South Jacksonville, Florida 32246

Re: K061507

Trade/Device Name: SonicWeld Rx Endobrow Fixation Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 1, 2006 Received: September 6, 2006

Dear Ms. Damato:

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. Damato

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 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 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 yours.

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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## Indications for Use

KOGISOT 510(k) Number (if known):

Device Name: SonicWeld Rx Endobrow Fixation

Indications For Use:

The SonicWeld Rx Endobrow Fixation will be used to support non-load bearing tissues of the craniofacial skeleton, including but not limited to endobrow fixation.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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