SYNTHES (USA) NEW/STERIAL ORBITAL PLATES

K031761 · Synthes (Usa) · JEY · Sep 3, 2003 · Dental

Device Facts

• Record ID: K031761
• Device Name: SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Sep 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Craniofacial 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 Orbital Plates are metallic bone fixation devices used in craniofacial and midface surgery. Plates are manufactured from CP Titanium and provided in various shapes and sizes to accommodate patient anatomy. Devices are intended for single use and are supplied sterile or non-sterile. Surgeons utilize these plates to stabilize bone segments during reconstructive or trauma procedures. The plates function as mechanical fixation components to support bone healing and structural integrity in the craniofacial skeleton.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Material: CP Titanium. Form factor: Various shapes and sizes of bone plates. Intended for single use. Sterilization: Sterile or non-sterile.

Indications for Use

Indicated for patients requiring surgical intervention for midface and craniofacial skeleton trauma, craniofacial surgery, reconstructive procedures, or 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 Maxillofacial Titanium Micro Set
• Synthes Orbital Mesh Plates

Submission Summary (Full Text)

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K031761

SEP = 3 2003

## Summary of Safety and Effectiveness Information 3.0

| SPONSOR: | Synthes (USA) |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1690 Russell Road |
| | Paoli, PA 19301 |
| | [phone] |
| | Contact: Lisa M. Boyle |
| DEVICE NAME: | Orbital Plates |
| CLASSIFICATION: | Class II , 21 CFR 888.3030: Single/multiple component metallic bone<br>fixation appliances and accessories |
| PREDICATE DEVICE: | Synthes Maxillofacial Titanium Micro Set<br>Synthes Orbital Mesh Plates |
| DEVICE DESCRIPTION: | The Synthes Orbital Plates come in a variety of shapes and sizes to meet the<br>anatomical need of the patient. The plates are sterile / non-sterile and for<br>single use only. |
| INTENDED USE: | The Synthes Craniofacial Plates are intended for use in selective trauma of<br>the midface and craniofacial skeleton; craniofacial surgery; reconstructive<br>procedures; and selective orthognathic surgery of the maxilla and chin. |
| MATERIAL: | CP Titanium |
| SUBSTANTIAL<br>EQUIVALENCE: | Documentation is provided which demonstrates that the Synthes Orbital<br>Plates are substantially equivalent to other legally marketed Synthes<br>devices. |

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2003

Ms. Lisa Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301

Re: K031761

Trade/Device Name: Synthes (USA) New / Sterile Orbital Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 5, 2003 Received: June 6, 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,

Susan Runne

Susan Runner, DDS, MA Interim 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 Statement 2.0

Page __ 1_________ of ________________________________________________________________________________________________________________________________________________________

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| 510(k) Number (if known): | K031761 |
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Device Name:

Indications:

The Synthes Craniofacial 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div>X</div> | OR | Over-The-Counter Use_ |
|----------------------|--------------|----|-----------------------|
| (Per 21 CFR 801.109) | | | |

| (Division Sign-Off) | |
|---------------------------------------------------------------------------------|----------|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K 031761 |

Confidential