THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

K021684 · Bioplate, Inc. · JEY · Jun 26, 2002 · Dental

Device Facts

• Record ID: K021684
• Device Name: THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
• Applicant: Bioplate, Inc.
• Product Code: JEY · Dental
• Decision Date: Jun 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified plate 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 nonload bearing fixation, including cranial bone 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 titanium alloy plates and screws for craniomaxillofacial surgery. Plates and screws provide rigid fixation for bone fractures and reconstructive procedures. System used by surgeons in clinical settings. Devices manufactured from titanium 6Al-4V alloy. Intended for single use in conjunction with other titanium/titanium alloy implants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plates: Titanium 6Al-4V alloy (ASTM F136/F1472). Screws: Titanium 6Al-4V ELI alloy (ASTM F136). Mechanical fixation system for craniomaxillofacial bone.

Indications for Use

Indicated for patients requiring treatment of fractures or reconstructive procedures of the craniomaxillofacial skeleton, including cranial and orbital bone fixation. For non-load bearing fixation only. Single use only.

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

• Wurzburg Titanium Mini Bone Plates and Bone Screws (K854886)
• Synthes (USA) Maxillofacial Titanium Micro Set (K912932)
• 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) (L944561)
• KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) (K944545)
• KLS-Martin L.P. KLS-Martin Osteosynthesis System (2.0mm) (K943347)
• Sofamor Danek Timesh System (K974017)
• Howmedica, Inc. Luhr Titanium Pan Fixation System (K945139)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

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

Bioplate, Inc. 6911 Melrose Avenue Los Angeles, CA 90038 [phone] [phone] (fax)

Contact Person: Carol E. Jones

# Trade Name of Device

Modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

#### Common name

Bone plates and bone screws

#### Classification name

Bone Plate (21 CFR 872.4760)

# Predicate Devices

- Walter Lorenz Surgical Instruments, Inc. (1) Wurzburg Titanium Mini Bone Plates and Bone Screws K854886
- (2) Synthes (USA) Maxillofacial Titanium Micro Set K912932
- (3) TiMesh Inc. Softplates and screws K923419, K923802, K973145
- (4) Techmedica, Inc. Anspach Fixation System K921801
- (5) Walter Lorenz Surgical Instruments, Inc. Ultra-micro Titanium Cranial Osteosynthesis System K910038
- (6) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.0mm) L944561

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- (7) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) K944545
- KLS-Martin L.P. (8) KLS-Martin Osteosynthesis System (2.0mm) K943347
- (છ) Sofamor Danek Timesh System K974017
- (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139

# Description of the device

Modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue.

The bone plates will be manufactured of a titanium 6AI-4V alloy that meets The American Society for Testing and Materials (A.S.T.M.) F136 and/or F1472 Standards. The screws will be manufactured of a titanium 6Al-4V ELI alloy that meets The American Society for Testing and Materials (A.S.T.M.) F136 Standard.

# Intended used of the device

The modified plate 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-load bearing fixation, including cranial bone fixation and orbital 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 plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery has the same indications for use as the Wurzburg, Synthes, TiMesh, and KLS-Martin predicate devices. All of the technical characteristis of the modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery 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/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. Inside the circle is an emblem featuring a stylized eagle with three human profiles incorporated into its body. The eagle's head faces left, and its wings are represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 2 6 2002

Ms. Carol E. Jones Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038

Re: K021684

Trade/Device Name: Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Codes: JEY and HRS Dated: May 22, 2002 Received: May 22, 2002

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.

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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 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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KO21684 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 plate 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 nonload bearing fixation, including cranial bone 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