CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM

K051293 · Ceremed , Inc. · JEY · Jun 14, 2005 · Dental

Device Facts

• Record ID: K051293
• Device Name: CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM
• Applicant: Ceremed , Inc.
• Product Code: JEY · Dental
• Decision Date: Jun 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cranion™ Cranial Fixation System intended for reconstruction of the craniomaxillofacial skeleton and for reattachment of cranial bone flaps after craniotomy procedures. The system is used to align and stabilized bony tissue while normal healing occurs. Each implantable component is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Device Story

Cranion™ Cranial Fixation System consists of titanium alloy plates, screws, clamps, and clips. Used by surgeons in clinical settings for craniomaxillofacial reconstruction and cranial bone flap reattachment post-craniotomy. Components provide mechanical alignment and stabilization of bony tissue to facilitate natural healing. System is for single-use only; compatible exclusively with other titanium/titanium alloy implants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy plates, screws, clamps, and clips. Mechanical fixation system for bone stabilization. Single-use implants. Compatible only with titanium/titanium alloy components.

Indications for Use

Indicated for reconstruction of the craniomaxillofacial skeleton and reattachment of cranial bone flaps following craniotomy procedures to align and stabilize bony tissue during healing.

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, Inc. Fixation System for Craniomaxillofacial Surgery (K023810)
• Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery (K021684)
• Bioplate, Inc. Zip Craniotomy Fixation System (K020880)
• Bioplate, Inc. Bioclip Craniotomy Fixation System (K013055)
• Bioplate, Inc. Zip Craniotomy Fixation System (K013050)
• Bioplate, Inc. Bioclip Craniotomy Fixation System (K011380)
• Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery (K992330)
• Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery (K972463)
• Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery (K953273)
• Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery (K943071)

Submission Summary (Full Text)

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| K051293 | |
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| Ceremed, Inc. | Page 7 - 1 |
| 510 (k) Premarket Notification - Cranion™ Cranial Fixation System | |

# VII - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS: Submitted by:

Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: [phone] Fax: [phone]

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JUN 1 4 2005

| Contact Person: | Tadeusz Wellisz, M.D. |
|--------------------|-----------------------------------------------------------------------------------------|
| Date Prepared | May 12, 2005 |
| Common/Usual Name: | Bone Plate, cranioplasty preformed, non-alterable |
| Proprietary Names: | Cranion™ Cranial Fixation System, FixLock™, Cranial Solutions, Ceremed™ Fixation System |

Classification Name:

Bone Plate, cranioplasty preformed, non-alterable

#### Predicate Devices

- 1. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K023810
- 2. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K021684
- 3. Bioplate, Inc. Zip Craniotomy Fixation System K020880
- 4. Bioplate, Inc. Bioclip Craniotomy Fixation System K013055
- 5. Bioplate, Inc. Zip Craniotomy Fixation System K013050
- 6. Bioplate, Inc. Bioclip Craniotomy Fixation System K011380
- 7. Bioplate, Inc.

..

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Fixation System for Craniomaxillofacial Surgery K992330

- 8. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K972463
- 9. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K953273
- 10. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K943071

## Description of the device:

The Cranion™ Cranial Fixation System includes a variety of plate configurations for different anatomical applications. Titanium alloy plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. Titanium alloy clamps and clips are included for the reattachment of cranial bone flaps after craniotomy procedures.

## Intended use:

The Cranion™ Cranial Fixation System intended for reconstruction of the craniomaxillofacial skeleton and for reattachment of cranial bone flaps after craniotomy procedures. The system is used to align and stabilized bony tissue while normal healing occurs. Each implantable component is intended for single use only and may be combined only with other titanium and titanium alloy implants.

## Substantial equivalence:

The Cranion™ Cranial Fixation System has the same indications for use as the predicate devices marketed by Bioplate, Inc. All of the technical characteristics of The Cranion™ Cranial 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 4 2005

Dr. Tadeusz Wellisz President Ceremed, Incorporated 3643 Lenawee Avenue Los Angeles, California 90016

Re: K051293

Trade/Device Name: Cranion™ Cranial Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 2, 2005 Received: June 6, 2005

Dear Dr. Wellisz:

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 - Dr. Wellisz

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Jenette y- Michael ms

Chiu Lin, Ph.D. 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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Page 10 - 1

510 (k) Premarket Notification - Cranion™ Cranial Fixation System

## X. INDICATIONS FOR USE:

K051293 510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________ Device Name: Cranion™ Cranial Fixation System

Indications For Use:

The Cranion™ Cranial Fixation System intended for reconstruction of the craniomaxillofacial skeleton and for reattachment of cranial bone flaps after craniotomy procedures. The system is used to align and stabilized bony tissue while normal healing occurs. Each implantable component is intended for single use only and may be combined only 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 EV ALUATION (ODE)

X Prescription Use_ (Per 21 CFR 801.109)

OR

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

Susan Rivas

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

510(k) Number:_

Division Sign-Off

510(k) Number