SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS

K031807 · Synthes (Usa) · DZL · Jul 2, 2003 · Dental

Device Facts

• Record ID: K031807
• Device Name: SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
• Applicant: Synthes (Usa)
• Product Code: DZL · Dental
• Decision Date: Jul 2, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 consists of bone screws used for intraosseous fixation. This submission adds 1.6 mm diameter self-drilling, self-tapping screws and 1.9 mm diameter emergency self-tapping screws in 3 mm lengths to the existing system. The device is used by surgeons in clinical settings for stabilization of bone segments during craniofacial and orthognathic procedures. The screws provide mechanical fixation to the bone, aiding in the healing and reconstruction of the midface and craniofacial skeleton.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Intraosseous fixation screws; self-drilling and self-tapping designs; diameters of 1.6 mm and 1.9 mm; length of 3 mm. Mechanical fixation device.

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

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Synthes Low Profile Neuro System

Submission Summary (Full Text)

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K031807

JUL മ 2003

# 3. 510(k) Summary:

| Submitter | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Bonnie Smith<br>[phone] |
| Name of the Device | Synthes Low Profile Neuro System - 3 mm Screws |
| Predicate Device | Synthes Low Profile Neuro System |
| Device Description | Synthes Ø1.6 mm Low Profile Neuro System self-drilling, self-tapping, and Ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system. |
| Intended Use | 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. |
| Substantial Equivalency: | Documentation is provided which demonstrates that the Synthes Low Profile Neuro System - 3 mm Screw Is substantially equivalent* to other legally marketed Synthes devices.<br><br>* The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol representing the human form, depicted as three overlapping profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 2 2003 JUL

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K031807

Trade/Device Name: Low profile Neuro System - 3 mm Screws Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: June 10, 2003 Received: June 11, 2003

Dear Ms. Smith:

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. Smith

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 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,

Süsen Ruinir

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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K031807

2. Indications for Use

### Special 510(k) Line Extension

#### INTENDED USE STATEMENT

510(k) Number (if known):

Device Name:

Indications

Low Profile Neuro System -- 3 mm Screws

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.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000

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

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Kein Muly fo MSR

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(Division Sign-Off)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | K031807 |
|----------------|---------|
|----------------|---------|

CONFIDENTIAL