SYNTHES LOW PROFILE NEURO SYSTEM

K022012 · Synthes (Usa) · JEY · Nov 1, 2002 · Dental

Device Facts

• Record ID: K022012
• Device Name: SYNTHES LOW PROFILE NEURO SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Low Profile Neuro System is 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 System comprises titanium plates, meshes, and screws; used for internal bone fixation in craniofacial and midface procedures. System provides structural support for bone segments during healing. Operated by surgeons in clinical or hospital settings. Device components are implanted to stabilize fractures or reconstruct skeletal anatomy. Benefits include stabilization of bone segments to facilitate proper healing and structural restoration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of titanium plates and meshes, and titanium alloy screws. Designed for cranio-facial fixation. Mechanical fixation device; no energy source or software components.

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.

Submission Summary (Full Text)

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## 3. Summary of Safety and Effectiveness Information

| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull<br>[phone] ext. 7191 |
| Name of the Device | Synthes Low Profile Neuro System |
| Device Classification(s) | Class II, §872.4760 -- Plate, Fixation, Bone<br>Class II, §882.5250 - Burr Hole Cover<br>Class II, §872.4880 - Screw, Fixation, Intraosseous |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes Low<br>Profile Neuro System to be substantially equivalent to other legally<br>marketed devices. |
| Device Description | The Synthes Low Profile Neuro System consists of titanium plates,<br>meshes, and screws in a variety of shapes and sizes designed for<br>various cranio-facial procedures. |
| Indications | The Synthes Low Profile Neuro System is intended for use in selective<br>trauma of the midface and craniofacial skeleton; craniofacial surgery;<br>reconstructive procedures; and selective orthognathic surgery of the<br>maxilla and chin. |
| Material | Plates & Meshes - Titanium<br>Screws - Titanium Alloy |

CONFIDENTIAL

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 1 2002 NOV

Mr. Matthew Hull Regulatory Affairs SYNTHES (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301-1222

Re: K022012

Trade/Device Name: Synthes Low Profile Neuro System Regulation Number: 872.4760, 872.4880 and 882.5250 Regulation Name: Bone Plate, Rotary Scaler and Burr Hole Cover Regulatory Class: II Product Code: JEY Dated: October 7, 2002 Received: October 15, 2002

Dear Mr. Hull:

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 vour 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.

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.

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Page 2 – Mr. Hull

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

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.

510(k) Number (if known):

Device Name:

Indications for Use:

ia

Synthes Low Profile Neuro System

The Synthes Low Profile Neuro System is 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

Susan Kunz

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

510(k) Number:

umber: k02012

CONFIDENTIAL Synthes(USA) Synthes Low Profile Neuro System 510(k)

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