MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

K023665 · Bioplate, Inc. · JEY · Nov 22, 2002 · Dental

Device Facts

• Record ID: K023665
• Device Name: MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
• Applicant: Bioplate, Inc.
• Product Code: JEY · Dental
• Decision Date: Nov 22, 2002
• Decision: SESE
• Submission Type: Special
• 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 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.

Device Story

System consists of modified titanium bone plates and titanium alloy screws for rigid fixation in craniomaxillofacial surgery. Plates are manufactured from commercially pure titanium; screws are titanium alloy. Device is used by surgeons in clinical settings for fracture treatment and reconstruction. Plates are fixed to bony tissue using screws. System is intended for single-use only and must be used with other titanium/titanium alloy implants. Provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Commercially pure titanium plates; titanium alloy screws. Non-load bearing fixation. Mechanical fixation via screws. Single-use. No software or electronic components.

Indications for Use

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

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 (K943071)
• Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K992330)
• Softplates and screws (K923419)
• Softplates and screws (K923802)
• Softplates and screws (K973145)
• Anspach Fixation System (K921801)
• Ultra-micro Titanium Cranial Osteosynthesis System (K910038)
• KLS-Martin Micro Osteosynthesis System (1.0mm) (L944561)
• KLS-Martin Micro Osteosynthesis System (1.5mm) (K944545)
• KLS-Martin Osteosynthesis System (2.0mm) (K943347)
• Timesh System (K974017)
• Luhr Titanium Pan Fixation System (K945139)

Submission Summary (Full Text)

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KO23645

# 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)

Carol E. Jones Contact Person:

### 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

- (1) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071
- Bioplate, Inc. (2) Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K992330
- TiMesh Inc. (3) Softplates and screws K923419, K923802, K973145

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- (4) Techmedica, Inc. Anspach Fixation System K921801
- Walter Lorenz Surgical Instruments, Inc. (5) Ultra-micro Titanium Cranial Osteosynthesis System K910038
- (6) KLS-Martin L.P. 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 Osteosynthesis System (2.0mm) K943347
- Sofamor Danek (9) 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 commercially pure titanium.

## 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

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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 Bioplate, 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/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized human figure in profile, with three faces overlapping each other. The emblem is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

Food and Drug Administration 9200 Corporate Boulevard

# NOV 2.2 2002

Mr. Carol E. Jones Chief Operating Officer Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California · 90038

Re: K023665

Trade/Device Name: Modified Plate Design for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: October 31, 2002 Received: October 31, 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 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.

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### Page 2 – Mr. Jones

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,

Patricia Quearity for

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 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.

Kein Mulins for Susan Runner

esthesiology. General Hospital. 510(k) Number.

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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)