BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES

K983885 · Howmedica, Inc. · JEY · Jan 29, 1999 · Dental

Device Facts

• Record ID: K983885
• Device Name: BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES
• Applicant: Howmedica, Inc.
• Product Code: JEY · Dental
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Leibinger Burr Hole Covers are designed to be used with fixation screws to cover burr holes of various diameters in the craniofacial skeleton in order to provide good cosmetic results and protection of the underlying soft tissues and brain. This device can also be used to secure cranial bone flaps. The Leibinger Two and Four-Hole Straight Plates are intended for fixation of small bones, including the craniofacial skeleton and midface bones, the fixation of facial bones following elective osteotomies and internal fixation of fractures of the hand. The Leibinger Temporal Gap Plates are intended for use with patients requiring reconstruction of the cranial area, including the sub-temporal regions. These plates provide fixation and stabilization of cranial bone flaps.

Device Story

Leibinger Burr Hole Covers, Two/Four-Hole Straight Plates, and Temporal Gap Plates are titanium bone fixation devices. Plates feature holed configurations for attachment to bone via screws. Burr hole covers provide cosmetic coverage and soft tissue/brain protection; straight plates provide structural support for small bone/hand fractures and osteotomies; temporal gap plates stabilize cranial bone flaps. Used by surgeons in clinical settings for craniofacial and hand reconstruction. Devices provide mechanical stabilization of bone segments to facilitate healing and anatomical reconstruction.

Clinical Evidence

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

Technological Characteristics

Titanium plates and covers; 0.5mm thickness; holed configuration for screw fixation; mechanical stabilization principle; non-active, implantable device.

Indications for Use

Indicated for patients requiring craniofacial reconstruction, fixation of small bones (craniofacial skeleton, midface, hand), stabilization of cranial bone flaps, or internal fixation of fractures. Used following elective osteotomies or for covering burr holes.

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 Plating System
• Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates
• Titanium Rigid Fixation & Bone Grafting - TiMesh Inc.
• Luhr® Pan Fixation System

Submission Summary (Full Text)

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JAN 29 1999

K9833885

### 510(k) Summary

Burr Hole Covers Proprietary Name: Burr Hole Covers Common Name: Burr Hole Cover 882.5250 Classification Name & Reference Requiatory Class: ll NE (84) GXR Device Product Code:

Joseph Volpe For information contact: Senior Regulatory Affairs Specialist Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] Fax: [phone]

Date prepared: October 29, 1998

The Leibinger Burr Hole Covers are designed to be used with Intended use: fixation screws to cover burr holes of various diameters in the craniofacial skeleton in order to provide good cosmetic results and protection of the underlying soft tissues and brain. This device can also be used to secure cranial bone flaps.

The Burr Hole Cover has a segmented plate-like structure. These Description: Burr Hole Covers are 0.5mm thick and are comprised of four different configurations.

Substantial equivalence;

The substantial equivalence of these components is based on an equivalence in the intended use, materials, design, and operational principles to other predicate devices used for covering burr holes such as the Wurzburg Titanium Mini Bone Plating System and the Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates.

0789-205-0599970

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## 510(k) Summary

| Proprietary Name: | Craniomaxillofacial Plates |
|------------------------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Small Bone Plates |
| Classification Name &<br>Reference | Single/Multiple Component Metallic Bone Fixation<br>Appliances and Accessories (21 CFR 888.3030) |
| Regulatory Class: | II |
| Device Product Code: | OR (87) HRS |

| For information contact: | Joseph Volpe<br>Senior Regulatory Affairs Specialist<br>Howmedica Inc.<br>359 Veterans Boulevard<br>Rutherford, NJ 07070<br>Telephone: [phone]<br>Fax: [phone] |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Date prepared: October 29, 1998

The Leibinger Two and Four-Hole Straight Plates are intended for Intended use: fixation of small bones, including the craniofacial skeleton and midface bones, the fixation of facial bones following elective osteotomies and internal fixation of fractures of the hand.

The Titanium Two and Four-Hole Straight Plates are holed plates Description: which are attached to bone using screw fixation. They are similar in design to the straight plates of the Wurzburg Titanium Mini Bone Plating System. These plates are 0.5mm thick.

Substantial equivalence:

The substantial equivalence of these components is based on an equivalence in the intended use, materials, design, and operational principles to other predicate devices used for fixation of small bones, craniofacial skeleton, midface bones and hand, such as the Titanium Rigid Fixation & Bone Grafting - TiMesh Inc., Wurzburg Titanium Mini Bone Plating System and the Luhr® Pan Fixation System.

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#### 510(k) Summary

| Proprietary Name: | Craniomaxillofacial Plates |
|------------------------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Small Bone Plates |
| Classification Name &<br>Reference | Single/Multiple Component Metallic Bone Fixation<br>Appliances and Accessories (21 CFR 888.3030) |
| Regulatory Class: | II |
| Device Product Code: | OR (87) HRS |

For information contact:

Joseph Volpe Senior Regulatory Affairs Specialist Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] Fax: [phone]

Date prepared: October 29, 1998

The Leibinger Temporal Gap Plates are intended for use with Intended use: patients requiring reconstruction of the cranial area, including the sub-temporal regions. These plates provide fixation and stabilization of cranial bone flaps.

Description: The Titanium Temporal Gap Plates are holed plates which are attached to bone using screw fixation. The configurations vary to accommodate the level of reconstruction required for the patient's anatomy.

Substantial equivalence:

The substantial equivalence of these components is based on an equivalence in the intended use, materials, design, and operational principles to other predicate devices used for patients requiring reconstruction of the cranial area, including the subtemporal regions. These plates provide fixation and stabilization of cranial bone flaps; bone gaps and defects; and fractures such as the Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates and the Wurzburg Titanium Mini Bone Plating System.

60.9 400.0M 05:91 66.52 MAC 0789-205-059977

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Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 29 1999

Mr. Joseph Volpe Senior Regulatory Affairs Specialist Howmedica, Incorporated 359 Veterans Boulevard Rutherford, New Jersey 07070

Re: K983885 Burr Hole Covers, Craniomaxillofacial Plates Trade Name: Requlatory Class: II Product Code: JEY October 30, 1998 Dated: Received: November 2, 1998

Dear Mr. Volpe:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Volpe

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA deboring of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets productions, 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 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 ene regaracion" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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

Enclosure

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#### Indications for Use

510(k) Number (if known):

Device Name: Leibinger Burr Hole Covers

Indications for Use:

The Covers are intended for use in patients requiring craniofacial reconstruction to cover burr holes of various diameters in the craniofacial skeleton in order to provide good cosmetic results and protection of the underlying soft tissues and brain. This device can also be used to secure cranial bone flaps.

# (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)

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Puaro

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.

66.52 MAC

OR

0289-205050598700

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### Indications for Use

510(k) Number (if known):

Device Name: Leibinger Two and Four-Hole Straight Plates

OR

Indications for Use:

The Plates are intended for use in patients requiring craniofacial fixation of small bones, craniofacial skeleton, midface bones and hand. These plates provide structure and support following elective osteotomies and internal fixation of fractures of the hand.

## (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) Over-The-Counter Use

(Optional Format 1-2-96)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

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#### Indications for Use

510(k) Number (if known):

Device Name: Leibinger Temporal Gap Plates

Indications for Use:

The Plates are intended for use in patients requiring reconstruction of the cranial area, including the sub-temporal regions. These plates provide fixation and stabilization of cranial bone flaps.

# (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)

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Punner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices ાટવિદ્વ 510(k) Number _

OR