SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)

K050606 · Synthes (Usa) · DZL · Apr 6, 2005 · Dental

Device Facts

• Record ID: K050606
• Device Name: SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
• Applicant: Synthes (Usa)
• Product Code: DZL · Dental
• Decision Date: Apr 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes 1.0mm Ti. Cortex screws are intended for use as follows: Specific Indications: Nasoethmoidal fractures Infraorbital area fractures Frontal sinus wall fractures Infant craniofacial surgery General Indications: Maxillofacial surgery

Device Story

Synthes 1.0mm Ti. Cortex screws are titanium fixation devices designed for maxillofacial and craniofacial surgical procedures. The screws feature a self-drilling design, flat head profile with rounded edges, and a cruciform recess. Available in lengths from 2-4 mm, these screws are used by surgeons to provide bone fixation in the craniofacial region. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy construction; self-drilling screw design; flat head profile with rounded edges and cruciform recess; lengths 2-4 mm; 1.0mm diameter; intraosseous fixation.

Indications for Use

Indicated for patients requiring fixation in nasoethmoidal, infraorbital, and frontal sinus wall fractures, and for infant craniofacial surgery and general maxillofacial surgery.

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 1.0 / 1.2 mm Craniofacial Screws
• KLS Martin 1.0mm System Center-Drive Screw System

Submission Summary (Full Text)

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| 3.0 | 510(k) Summary | APR 6 | 2005 | Page 1 | of 1 |
|-----|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--------|------|
| | Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] | | | |
| | Device Name: | Synthes 1.0mm Ti. Cortex, Self-drilling Screws (Craniofacial) | | | |
| | Classification: | 21 CFR 872.4880: Screw, Fixation, Intraosseous | | | |
| | Predicate Device: | Synthes 1.0 / 1.2 mm Craniofacial Screws<br>KLS Martin 1.0mm System Center-Drive Screw System | | | |
| | Device Description: | The 1.0mm Ti. Cortex Screws are self-drilling, have a flat head<br>profile with rounded edges with a cruciform recess, and are<br>available in lengths from 2 - 4 mm. | | | |
| | Intended Use: | The Synthes 1.0mm Ti. Cortex screws are intended for use as follows:<br>Specific Indications:<br>Nasoethmoidal fractures Infraorbital area fractures Frontal sinus wall fractures Infant craniofacial surgery General Indications: Maxillofacial surgery | | | |
| | Substantial<br>Equivalence: | Documentation is provided which demonstrates that the Synthes<br>1.0mm Ti. Cortex Screws are substantially equivalent to other<br>legally marketed devices.<br><br>The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Federal Food, Drug and Cosmetic Act, as amended<br>and as applied under 21CFR 807, Subpart E under which a device<br>can be marketed without premarket approval or reclassification. A<br>determination of substantial equivalency under this notification is<br>not intended to have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence<br>herein shall be construed as an admission against interest under the<br>US Patent Laws or their application by the courts. | | | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.

2005 APR 6

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K050606

Trade/Device Name: Synthes (USA) 1.0mm Ti. Cortex, Self-Drilling Screws Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: March 9, 2005 Received: March 10, 2005

Dear Ms. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to rowed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to are road Cosmetic Act (Act) that do not require approval of a premarket the Federal F 00d; Drag, drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 IT your device is olassinod (500 modditional controls. Existing major regulations afficting (1 MA), it may of subject to tax and 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. Anderson

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 mean that I Drimas made statutes and regulations administered by other Federal agencies. or the Act of any I eact is requirements, including, but not limited to: registration r ou inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ilsung (21 et read on 1), a quality systems (QS) regulation (21 CFR Part 820); and if requirents as between as 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) This letter will and in yoursely of substantial equivalence of your device to a promainer level 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), rr you docute of 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 maj overn 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 vours.

Chu Lin, Ph.D.

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

510(k) Number (if known):

Synthes (USA) 1.0mm Ti. Cortex. Self-drilling Screws

K050606

Device Name:

2.0

Indications for Use:

The Synthes 1.0mm Ti. Cortex, Self-drilling Screws are intended for use as follows:

Specific Indications:

- Nasoethmoidal fractures .
- Infraorbital area fractures .
- Frontal sinus wall fractures .
- Infant craniofacial surgery .

General Indications:

- Maxillofacial surgery .
Prescription Use _ X ____________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

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)

| | <i>Suan Runne</i> |
|---------------------------------------------------------------------------------|-------------------|
| Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| (k) Number: | 1050606 |