THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

{0}------------------------------------------------ K031028 # Summary of Safety and Effectiveness ### Submitter's name, address, telephone number and contact person: Bioplate, Inc. 3643 Lenawee Avenue Los Angeles, CA 90016 (310) 815-2100 (310) 815-2126 (fax) Contact Person: Judy Sokua # Trade Name of Device Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery ## Common name Bone Plates # Classification name Bone Plate (21 CFR 872.4760) # Predicate Devices - (1) Bioplate, Inc. Modified Screw Design for use with Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K022890 - (2) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K021684 - (3) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463 {1}------------------------------------------------ - (4) Bioplate. Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071 ## Description of the device The modified screw designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and may be used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue. ### Intended used of the device The modified screw designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of craniofacial fractures, reconstructive procedures, and non-load bearing fixation including, maxillofacial fixation, cranial bone fixation, orbital fixation and brow fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants. # Comparison of the devices' technological characteristics with those of predicate devices The modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surqery have the same indications for use as the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K943071 - K972463 - K021684 -K022890) predicate devices. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 8 2003 Ms. Carol E. Jones Chief Operating Officer BioPlate, Incorporated 3643 Lenawee Avenue Los Angeles, California 90016 Re: K031028 Trade/Device Name: Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 31, 2003 Received: April 9, 2003 Dear Ms. Jones: 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. {3}------------------------------------------------ #### Page 2 - Ms. Jones 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. Susan Renner Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 # 510(k) Number (if known): The Bioplate® Rigid Fixation Bone Plating System for Device Name: Craniomaxillofacial Surgery. Indications for Use: The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation. including cranial bone fixation, brow fixation and orbital fixation. Each device 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 | X | |----------------------|---| | (Per 21 CFR 801.109) | | Over-The-Counter Use (Optional Format 1-2-96) Kei Ruby for Msk (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices OR 510(k) Number: K 031028