SYNTHES 1.3 MM SELF-DRILLING SCREW

K983485 · Synthes (Usa) · DZL · Dec 21, 1998 · Dental

Device Facts

• Record ID: K983485
• Device Name: SYNTHES 1.3 MM SELF-DRILLING SCREW
• Applicant: Synthes (Usa)
• Product Code: DZL · Dental
• Decision Date: Dec 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 1.3 mm Self-Drilling Screws are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Story

Synthes 1.3 mm Self-Drilling Screws are orthopedic fixation devices used in craniofacial and midfacial surgery. The screws feature self-drilling and self-tapping tips and a stardrive recessed head. They are available in lengths ranging from 4 mm to 6 mm. The device is used by surgeons in clinical settings to provide bone fixation during trauma repair, reconstructive procedures, or orthognathic surgery. The screws are implanted to stabilize bone segments, facilitating healing and structural alignment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Ti-6Al-7Nb alloy. Design: Self-drilling, self-tapping tip with stardrive recessed head. Dimensions: 1.3 mm diameter, 4 mm to 6 mm lengths. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring fixation in the midface and craniofacial skeleton, including trauma, reconstructive procedures, and 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 Midfacial System (K953806)

Submission Summary (Full Text)

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DEC 2 1 1998

Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person inside of a circle. To the right of the word is a small circle with an R inside of it, indicating that the word is a registered trademark. The word is written in a sans-serif font.

Attachment VI:

SUBMITTER

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

Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone]

Contact: Sheri L. Musgnung

COMMON OR USUAL NAME

Screw, Fixation Bone

DEVICE CLASSIFICATION: Class II, 21 CFR 888.3030

Synthes Midfacial System (K953806) PREDICATE DEVICE:

Synthes 1.3 mm Self-Drilling Screws feature self-drilling self-DESCRIPTION: tapping tips, stardrive recessed head, and are available in lengths ranging from 4 mm - 6 mm.

- Synthes 1.3 mm Self-Drilling Screws are intended for selective INTENDED USE: trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
MATERIAL:

.

Ti-6Al-7Nb

CONFIDENTIAL

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VGV3485

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1998

Ms. Sheri L. Musgnung Requlatory Affairs Associate Synthes® (USA) 1690 Russell Road Post Office Box 1766 Paoli. Pennsylvania 19301

K983485 Re : Synthes® 1.3 MM Self-Drilling Screw Trade Name: Requlatory Class: II Product Code: DZL October 2, 1998 Dated: Received: October 5, 1998

## Dear Ms. Musgnung:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Musgnung

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-20#1 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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## Indications for Use Statement 2.0

Page

510(k) Number (if known):

Synthes 1.3 mm Self-Drilling Screws Device Name:

Indications For Use:

Synthes 1.3 mm Self-Drilling Screws are intended for 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 ﮧ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Susan Runne

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K983485 510(k) Number _

CONFIDENTIAL