SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS

K980199 · Synthes (Usa) · DZL · Apr 17, 1998 · Dental

Device Facts

• Record ID: K980199
• Device Name: SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS
• Applicant: Synthes (Usa)
• Product Code: DZL · Dental
• Decision Date: Apr 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, they 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 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws consist of bone plates in mesh, T, L, and Z configurations, secured with self-tapping or emergency screws. Used by surgeons in clinical settings for internal fixation of the midface and craniofacial skeleton. The device provides mechanical stabilization of bone segments during healing following trauma or reconstructive/orthognathic surgical procedures. It functions as a permanent implant to maintain anatomical alignment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bone plates and screws available in 1.5 mm and 2.0 mm sizes, with 2.4 mm emergency screws. Configurations include mesh, T, L, and Z plates. Metallic fixation hardware designed for internal bone stabilization.

Indications for Use

Indicated for patients requiring fixation for 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 Midfacial System (K953806)

Submission Summary (Full Text)

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SYNTHES

APR 16 1998

Attachment VI:

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

K

SUBMITTER

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

Contact: Sheri L. Musgnung

COMMON OR USUAL NAME

Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Plate, Bone

1980199

Class II, 21 CFR 888.3030 and 872.4760

CLASSIFICATION:

PREDICATE DEVICE:

Synthes Midfacial System (K953806)

DESCRIPTION:

DEVICE

INTENDED USE:

Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L-, and Z- plate configurations, and attach to bone via 1.5 mm and 2.0 mm self-tapping screws, and 2.0 mm and 2.4 mm emergency screws.

Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and craniofacial skeleton; surgery; reconstructive procedures; craniofacial and selective orthognathic surgery of the maxilla and chin.

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 17 1998

Ms. Sheri L. Musqnung Regulatory Affairs Associates Synthes® (USA) 1690 Russell Road Post Office Box 1766 19301 Paoli, Pennsylvania

Re : K980199 Synthes® (USA) 1.5mm/2.0mm Orthognathic Trade Name: Maxillary Plates and Screws Requlatory Class: II Product Code: DZL January 19, 1998 Dated: Received: January 20, 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 findinq 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 requlation (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 [phone]g or [phone] or at its internet address "http://www.fda.gpv/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## TES®

SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone [phone]

Page of

K980199 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Synthes (USA)1.5 mm / 2.0 mm Orthognathic Maxillary Plates Device Name: and Screws

Indications For Use:

Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, they 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 (Per 21 CFR 801.109) OR

Over-The-Counter Use

Herold W. Shapiro
(Division Sign-Off)

ental, Infection Control. and General Hospital 510(k) Number