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

K022033 · Bioplate, Inc. · JEY · Jul 19, 2002 · Dental

Device Facts

• Record ID: K022033
• Device Name: STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM
• Applicant: Bioplate, Inc.
• Product Code: JEY · Dental
• Decision Date: Jul 19, 2002
• 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 in non-load bearing fixation, including, but not limited to 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 implants.

Device Story

System consists of sterile titanium bone plates and screws for craniomaxillofacial fixation. Plates manufactured from commercially pure titanium and titanium 6Al-4V ELI alloy; screws manufactured from titanium 6Al-4V ELI alloy. Device used by surgeons in clinical settings for non-load bearing fixation, including cranial and brow procedures, and fracture/reconstructive surgery. Provides mechanical stabilization of bony tissue. Single-use components; sterilized via gamma radiation. Clinical benefit derived from secure fixation of bone segments during healing or reconstruction.

Clinical Evidence

Bench testing only. Sterilization and packaging validation studies performed to ensure sterility.

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67) and titanium 6Al-4V ELI alloy (ASTM F136). Form factor: Bone plates and screws of varying lengths. Sterilization: Gamma radiation. No software or electronic components.

Indications for Use

Indicated for non-load bearing fixation in patients requiring cranial bone fixation, brow fixation, or treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Single use only; must be used with other 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

• Walter Lorenz Surgical Instruments, Inc. Lorenz 1.5mm Neuro Pack/Lorenz 2.0FT Plates (K972322)
• 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 Oseosynthesis 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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K022033

# 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

Sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System

#### Common name

Bone plates and bone screws

#### Classification name

Bone Plate (21 CFR 872.4760)

#### Predicate Devices

- Walter Lorenz Surgical Instruments, Inc. (1) Lorenz 1.5mm Neuro Pack/Lorenz 2.0FT Plates (Sterile Version) . K972322
- (2) Synthes (USA) Maxillofacial Titanium Micro Set K912932
- (3) TiMesh Inc. Softplates and screws K923419, K923802, K973145
- (4) Techmedica, Inc. Anspach Fixation System K921801

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- Walter Lorenz Surgical Instruments, Inc. (5) Ultra-micro Titanium Cranial Osteosynthesis System K910038
- KLS-Martin L.P. (6) KLS-Martin Micro Osteosynthesis System (1.0mm) L944561
- KLS-Martin L.P. (7) KLS-Martin Micro Osteosynthesis System (1.5mm) K944545
- KLS-Martin L.P. (8) KLS-Martin Oseosynthesis System (2.0mm) K943347
- Sofamor Danek (છ) Timesh System K974017
- (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139

# Description of the device

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System includes a variety of plate confiqurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. 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 unalloved, commercially pure titanium and titanium 6AI-4V ELI allov. The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards and The American Society for Testing and materials (A.S.T.M.) F136 Standard. 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.

The plate and screw kit confiqurations are sterilized using gamma radiation sterilization methods. Successful completion of sterilization validation and packaging validation studies provides a high level of

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assurance that sterility of the devices has been achieved and can be maintained.

### Intended used of the device

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including, but not limited to 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 implants.

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

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System have the same indications for use as the Bioplate, Inc., Wurzburg, Synthes, TiMesh, and KLS-Martin predicate devices. All of the technical characteristics of the sterile plate and screw kit configurations for use with the 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 9 2002

Bioplate. Incorporated C/O Mr. Bruce F. Mackler Heller. Ehrman, White & Mcauliffe 815 Connecticut Avenue NW Washington, D. C. 20006-4004

Re: K022033

Trade/Device Name: Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 10, 2002 Received: June 21, 2002

Dear Mr. Mackler:

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 vour 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.

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Page 2 - Mr. Mackler -

You must comply with all the Act's requirements, including, but not limited to: registration ないではないとなるとなるならなくなる 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

Timothy A. Ulatowski 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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Device Name: Sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System

Indications for Use:

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and. 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 | <span></span> |
|----------------------|---------------|
| (Per 21 CFR 801.109) | |

OR

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

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

| 510(k) Number | |
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