SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES

K033160 · Synthes (Usa) · JEY · Oct 9, 2003 · Dental

Device Facts

• Record ID: K033160
• Device Name: SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Oct 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Low Profile Neuro Contourable Mesh Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Story

Synthes Low Profile Neuro Contourable Mesh Plates are titanium bone fixation devices; designed for use in cranio-facial procedures; including trauma, reconstruction, and orthognathic surgery. Plates are provided sterile; intended for use by surgeons in clinical settings to stabilize bone segments. Device provides mechanical support to the craniofacial skeleton; facilitating healing and structural alignment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium. Form factor: Low profile mesh plates of various shapes and sizes. Sterilization: Provided sterile. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring fixation in selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla and chin.

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

• Synthes Low Profile Neuro System

Submission Summary (Full Text)

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OCT - 9 2003

K033160

## Summary of Safety and Effectiveness Information [510(k) Summary] 3.0

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Low Profile Neuro Contourable Mesh Plates |
| CLASSIFICATION: | Class II , 21 CFR 872.4760 - Plate, Fixation, Bone |
| PREDICATE DEVICE: | Synthes Low Profile Neuro System |
| DEVICE DESCRIPTION: | The Synthes Low Profile Neuro Contourable Mesh Plates are manufactured<br>from Titanium and consists of a variety of shapes and sizes designed for<br>various cranio-facial procedures. These plates are now available to the user<br>sterile. |
| INTENDED USE: | The Synthes Low Profile Neuro Contourable Mesh Plates are intended for<br>use in selective trauma of the midface and craniofacial skeleton;<br>craniofacial surgery; reconstructive procedures; and selective orthognathic<br>surgery of the maxilla and chin. |
| MATERIAL: | Titanium |
| SUBSTANTIAL<br>EQUIVALENCE: | Documentation is provided which demonstrates that the Synthes Low<br>Profile Neuro Contourable Mesh Plates are substantially equivalent to other<br>legally marketed Synthes devices. |

:

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head facing right, composed of three thick, curved lines. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 9 - 2003

Ms. Lisa M. Boyle Regulatory Associate Synthes, (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K033160

Trade/Device Name: Synthes (USA) Low Profile Neuro Contourable Mesh Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 26, 2003 Received: September 30, 2003

Dear Ms. Boyle:

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. Boyle

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/dsma/dsmamain.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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## 2.0 Indications for Use Statement

| Page | 1 of 1 |
|------|--------|
|------|--------|

| 510(k) Number (if known): | K033160 |
|---------------------------|---------------------------------------------------------|
| Device Name: | Synthes (USA) Low Profile Neuro Contourable Mesh Plates |
| Indications: | |

The Synthes Low Profile Neuro Contourable Mesh Plates are intended for use in selective trauma of the
midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective
orthognathic surgery of the maxilla and chin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|----------------------|
|---------------------------------------|----|----------------------|

Nor (Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital, Division of Ancolnectors, Infection Control.

Surfer

510(k) Number._

Special 510(k): Confidential Synthes (USA) Low Profile Neuro Contourable Mesh Plates