BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

K062819 · Bioplate, Inc. · GXN · Dec 4, 2006 · Neurology

Device Facts

• Record ID: K062819
• Device Name: BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
• Applicant: Bioplate, Inc.
• Product Code: GXN · Neurology
• Decision Date: Dec 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surgical decompression procedures of the posterior fossa or transcervical skullbased approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone fixation. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

Device Story

Bioplate Rigid Fixation Bone Plating System consists of titanium plates and screws for craniomaxillofacial surgery. Modified plate designs provide structural support for cranial reconstruction following decompression procedures; used in non-load bearing fixation. System components are implanted by surgeons in clinical settings. Device provides mechanical stabilization of bone segments; facilitates healing; intended for single use only. System utilizes titanium and titanium alloy materials to ensure biocompatibility and rigid fixation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed from unalloyed commercial pure Grade 1, 2, and 4 titanium and titanium alloys. System includes plates and screws of varying diameters and lengths. Designed for rigid fixation in craniomaxillofacial applications. Single-use, non-sterile (implied), mechanical fixation device.

Indications for Use

Indicated for patients requiring cranial reconstruction following posterior fossa or transcervical skull-based surgical decompression, including Chiari I Malformation treatment, and for non-load bearing cranial bone fixation.

Regulatory Classification

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• Modified Plate designs for use with the Bioplate® Rigid Fixation Bone plating System for Craniomaxillofacial Surgery (K021864)
• Plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone plating System for Craniomaxillofacial Surgery (K992330)
• The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K980983)
• The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K972463)

Reference Devices

• The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K953273)
• The Bioplate® Titanium Fixation System (K943071)
• The Wurzberg Titanium Mini Bone Plates and Bone Screws (K854886)
• Maxillofacial Titanium Micro Set (K854886)
• The Synthes Maxillofacial Titanium Micro Set (K912932)

Submission Summary (Full Text)

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- Summary of Safety and Effectiveness VI.
# 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

JEC - 4 2006

#### Trade name of Device:

Modified plate design for use in conjunction with the Bioplate® Rigid Bone Plating system for Craniomaxillofacial surgery.

#### Common Name:

Bone Fixation Plates

### Device Classification:

Class 2, 21 CFR 882.5330 GXN

Predicate Devices:

Modified Plate designs for use with the Bioplate® Rigid Fixation Bone plating System for Craniomaxillofacial Surgery (K021864)

Plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone plating System for Craniomaxillofacial Surgery (K992330)

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K980983).

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K972463).

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The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K953273).

The Bioplate® Titanium Fixation System (K943071).

The Wurzberg Titanium Mini Bone Plates and Bone Screws (K854886) and the Maxillofacial Titanium Micro Set (K854886).

The Synthes Maxillofacial Titanium Micro Set (K912932).

# Description of the Device:

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery include a variety of plate configurations for different anatomical applications. Unalloyed commercial pure Grade 1, 2 and 4 titanium, titanium alloy plates as well as titanium alloy screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial tissues.

## Intended Use of the Device:

The modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surgical decompression procedures of the posterior fossa or transcervical skullbased approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone fixation. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

## Comparison of the device's technological characteristics with those of the 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bioplate, Inc. % Mr. Jesus T. Farinas Director, Quality Assurance/Regulatory/Affairs 3643 Lenawee Avenue Los Angeles, California 90016

DEC = 4 2006

Re: K062819

Trade/Device Name: Modified plate design for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 21 CFR 882.5330

Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: September 5, 2006 Received: September 25, 2006

Dear Mr. Farinas:

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. 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.

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Page 2 - Mr. Jesus T. Farinas

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 [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Loubara Buchud
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

Device Name: Modified plate design for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.

Indication for Use:

The modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surqical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone 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 the CDRH, Office of Evaluation (ODE)

X

Prescription Use (Per 21 CFR 801.109)

Barbara buchun

(Division Sign-Off) Division of General Restorative, and Neurological Devices

510(k) Number K062819

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