MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM

K082757 · Bioplate, Inc. · JEY · Oct 1, 2008 · Dental

Device Facts

• Record ID: K082757
• Device Name: MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
• Applicant: Bioplate, Inc.
• Product Code: JEY · Dental
• Decision Date: Oct 1, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant.

Device Story

Bioplate Titanium Fixation System consists of unalloyed commercially pure titanium (Grades 1, 2, 4) and titanium 6Al-4V ELI alloy plates and screws. Device provides non-load bearing fixation for craniomaxillofacial skeleton, including cranial and brow bone fixation and fracture/reconstructive procedures. System is intended for single-use only; must be used with other titanium/titanium alloy implants. Sterilized via gamma radiation using VD Max dose setting. Used by surgeons in clinical settings for bone stabilization.

Clinical Evidence

No clinical data. Substantial equivalence based on material compliance with ASTM standards (F67, F136) and successful sterilization/packaging validation studies.

Technological Characteristics

Materials: Unalloyed commercially pure titanium (Grades 1, 2, 4) and titanium 6Al-4V ELI alloy per ASTM F67 and ASTM F136. Form factor: Bone plates and screws of varying diameters/lengths. Sterilization: Gamma radiation (VD Max dose).

Indications for Use

Indicated for patients requiring non-load bearing fixation, including cranial and brow fixation, and treatment of fractures or reconstructive procedures of the craniomaxillofacial skeleton.

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.

Predicate Devices

• Sterile Plate & Screw Configurations for use with the Bioplate® Titanium Fixation System (K022033)
• Walter Lorenz instruments, Inc. Lorenz 1.5mm Neuro Pack/Lorenz 2.0FT plates (Sterile Version) (K972322)
• Synthes (USA) Maxillofacial Titanium Micro Set (K912932)

Reference Devices

• TiMesh Inc., Softplates and Screws (K923419, K923802, K973145)
• Techmedica, Inc., Anspach Fixation System (K921801)
• Walter Lorenz Surgical Instruments, Inc., Ultra-Micro Titanium Cranial Osteosynthesis System (K910038)
• KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.0mm) (K944561)
• KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) (K944545)
• KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (2.0mm) (K943347)
• Sofamor Danek Timesh System (K947017)
• Hwmedica, Inc., Luhr Titanium Pan Fixation System (K945139)

Submission Summary (Full Text)

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#### OCT 01 2008 Summary of Safety and Effectiveness VII.

# Submitter's name, address, telephone number and contact person:

Bioplate, Inc. 3643 Lenawee Avenue Los Angeles, CA, 90016 [phone] [phone] (fax)

Contact Person: Jesus Farinas

## Trade name of Device:

Modified Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System.

# Common Name:

Bone Fixation Plates and Bone Screws

### Device Classification:

Class 2, 21 CFR 872.4760 JEY

Predicate Devices:

Sterile Plate & Screw Configurations for use with the Bioplate® Titanium Fixation System (K022033)

Walter Lorenz instruments, Inc. Lorenz 1.5mm Neuro Pack/Lorenz 2.0FT plates ( Sterile Version) (K972322)

Synthes (USA) Maxillofacial Titanium Micro Set (K912932)

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TiMesh Inc., Softplates and Screws. (K923419, K923802, K973145)

Techmedica, Inc., Anspach Fixation System (K921801)

Walter Lorenz Surgical Instruments, Inc., Ultra-Micro Titanium Cranial Osteosynthesis System, (K910038)

KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.0mm) (K944561)

KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) (K944545)

KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (2.0mm)) (K943347)

Sofamor Danek Timesh System (K947017)

Hwmedica, Inc., Luhr Titanium Pan Fixation System (K945139)

#### Description of the Device:

The Bioplate® Titanium Fixation System includes a variety of plate configurations for different anatomical applications. Unalloyed commercially pure Grade 1, Grade 2 and Grade 4 titanium and titanium allov plates, and titanium allov screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial bony tissues. These materials have been implanted safely for many years. The predicate device had been approved under K022033.

The bone plates will be manufactured of unalloyed, commercially pure titanium and titanium 6A1-4V Eli alloy. The materials adhere to the American Society of Testing and Materials (A.S.T.M.) F67 Standards and

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the American Society of Testing and Materials ( A.S.T.M.) F136 Standard.. The screw will be manufactured of a titanium 6A1-4V Eli alloy that meets the American Society of Testing and Materials (A.S.T.M.) F136 Standard.

The plate and screw fit configurations are sterilized by gamma radiation sterilization, using VD Max dose setting method. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the device has been achieved and can be maintained.

#### Intended Use of the Device:

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant.

# Comparison of the device's technological characteristics with those of the predicate devices

The sterile plate and screw configurations for use with the Bioplate® Titanium Fixation System have the same indications for use as the Bioplate, Inc., Walter Lorenz, Synthes, TiMesh and KLS-Martin predicate devices. All the technical characteristics of the sterile plate and screw kit configurations for use Bioplate® Titanium Fixation System are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 01 2008

Mr. Jesus T. Farinas Director, Quality Assurance/Regulatory Affairs Bioplate, Incorporated 3643 Lenawce Avenue Los Angeles, California 90016-4310

Re: K082757

Trade/Device Name: Modified Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System Regulation Number: 872.4760 Regulation Name: Bone Platc Regulatory Class: Il Product Code: JEY Dated: September 15, 2008 Received: September 19, 2008

Dear Mr. Farinas:

We have reviewed your Section 51%(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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Th. Namuele fendre fore//

Chiu S. Lin, Ph. D Division 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) KO&2757

# Device Name: Modified Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System.

#### Indication for Use:

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of the CDRH, Office of Evaluation (ODE)

Sason Rurn

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: