THE BIOPLATE MANDIBLE FIXATION SYSTEM

K012910 · Bioplate, Inc. · JEY · Nov 20, 2001 · Dental

Device Facts

• Record ID: K012910
• Device Name: THE BIOPLATE MANDIBLE FIXATION SYSTEM
• Applicant: Bioplate, Inc.
• Product Code: JEY · Dental
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bioplate Mandible Fixation System is intended for use in the treatment of The Diopiate Manufic I ixation System of the facial skeleton and mandible, including iractares and 1000nbille is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Device Story

Bioplate Mandible Fixation System consists of modified plate and screw designs for internal fixation of facial skeleton and mandible fractures. Device used by surgeons in clinical settings to stabilize bone segments. System components are manufactured from titanium and titanium alloys. Device is for single-use only; intended to be used in conjunction with other compatible titanium implants to provide structural support during bone healing. No automated processing or software components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium and titanium alloys. Form factor: Plates and screws for mandible/facial skeleton fixation. Energy source: None (mechanical). Sterilization: Not specified. Software: None.

Indications for Use

Indicated for treatment of facial skeleton and mandible fractures. Intended for single use only in conjunction with other titanium and titanium alloy implants.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

Bioplate, Incorporate C/O Dr. Bruce F. Mackler Heller, Ehrman, White and Mcauliffe 1666 K Street NW, Suite 200 Washington, D.C. 20006-4004

Re: K012910

Trade/Device Name: The Bioplate Mandible Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plates and Bone Screws Regulatory Class: II Product Code: JEY Dated: August 30, 2001 Received: August 30, 2001

Dear Dr. Mackler:

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.

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 - Dr. Mackler

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

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NOV 2 0 2001

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Bioplate Inc. APPLICANT:

510(k) NUMBER: (if known): K012910

DEVICE NAME: Modified Plate and Screw designs for use in conjunction with The Bioplate Mandible Fixation System.

## INDICATIONS FOR USE:

The Bioplate Mandible Fixation System is intended for use in the treatment of The Diopiate Manufic I ixation System of the facial skeleton and mandible, including iractares and 1000nbille is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

(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)

Over-The-Counter-Use OR (Optional Format 1-2-96)

Susan Rump

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