MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

K023810 · Bioplate, Inc. · JEY · Dec 4, 2002 · Dental

Device Facts

• Record ID: K023810
• Device Name: MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
• Applicant: Bioplate, Inc.
• Product Code: JEY · Dental
• Decision Date: Dec 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified plates designs for use with 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.

Device Story

Bioplate Rigid Fixation Bone Plating System consists of modified titanium plates and screws for craniomaxillofacial surgery. Plates are used by surgeons to provide rigid fixation of bone segments during fracture repair or reconstructive procedures. Device is intended for non-load bearing applications. System components are implanted during surgery to stabilize bony tissue; they are intended for single use only. Benefit includes stabilization of craniomaxillofacial skeleton to facilitate healing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Commercially pure titanium (Grade 4) plates; titanium alloy screws. Materials conform to ASTM F67 standards. Mechanical fixation system for craniomaxillofacial bone.

Indications for Use

Indicated for patients requiring treatment of craniomaxillofacial skeleton fractures, reconstructive procedures, and non-weight bearing fixation (cranial, brow, and orbital). For single use only in conjunction with titanium/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.

Predicate Devices

• Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K021684)
• Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K980983)
• Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K972463)
• Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K953273)
• Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K943071)

Submission Summary (Full Text)

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K0238/0

#### Summary of Safety and Effectiveness DEC 0 4 2002

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

Bioplate, Inc. 6911 Melrose Avenue Los Angeles, CA 90038 [phone] [phone] (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. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K021684
- (2) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K980983
- (3) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463

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- Bioplate. Inc. (4) Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K953273
- (5) Bioplate. Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071

## Description of the device

The modified plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Commercially pure titanium plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxilloffacial bony tissue

The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards

## Intended used of the device

The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of craniofacial fractures, reconstructive procedures, and non-load bearing fixation including, maxillofacial fixation, cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium allov implants.

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

The modified plate design for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery has the same indications for use as the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surqery (K021684, K980983, K972463, K953273, and K943071) 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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like extensions, suggesting movement or flight.

Public Health Service

ood and Drug Administration 00 Corporate Boulevard Rockville MD 20850

DEC 04 2002

Ms. Judy Sokua Regulatory Affairs Associate Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038-3305

Re: K023810

Trade/Device Name: Modified Plate designed for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 14, 2002 Received: November 15, 2002

Dear Ms. Sokua:

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.

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#### Page 2 - Ms. Sokua

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

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## 510(k) Number (if known):

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

Indications for Use:

The modified plates designs for use with 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 | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

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

Suxin Rair

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

KCd 3810 510(k) Number _