MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

K070901 · Bioplate, Inc. · GXN · Jun 15, 2007 · Neurology

Device Facts

• Record ID: K070901
• Device Name: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
• Applicant: Bioplate, Inc.
• Product Code: GXN · Neurology
• Decision Date: Jun 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bioplate® ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Device Story

Bioplate® ZIP® Craniotomy Fixation System consists of two circular caps in parallel configuration connected by internal serrated post; available in 12mm to 20mm diameters. Used in neurosurgical procedures to reattach cranial bone flaps; provides mechanical alignment and stabilization of bone segments during healing. Operated by surgeons in clinical/OR settings. Single-use device; compatible only with titanium and titanium alloy implants. Provides physical fixation to facilitate bone union.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical fixation device; consists of two circular caps and internal serrated post. Materials: Titanium and titanium alloy. Dimensions: 12mm to 20mm cap diameters. Single-use. No software or electronic components.

Indications for Use

Indicated for patients undergoing craniotomy procedures requiring reattachment of a cranial bone flap to the surrounding cranium for alignment and stabilization of bony tissue during healing.

Regulatory Classification

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• Bioplate® ZIP® Craniotomy Fixation System (K013050)
• Device Modification of the Bioplate® ZIP® Craniotomy Fixation System (K020088)

Submission Summary (Full Text)

{0}------------------------------------------------

#### VI. Summary of Safety and Effectiveness

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

Bioplate, Inc. 3643 Lenawee Avenue Los Angeles, CA, 90016 [phone] [phone] (fax)

Contact Person: Jesus Farinas

## Trade name of Device:

Modified design of the Bioplate® ZIP® Craniotomy Fixation System. (K013050, K020088)

### Common Name:

Plate, Cranioplasty, Preformed, Non-Alterable

# Device Classification:

Class 2, 21 CFR 882.5330 GXN

Predicate Devices:

- (1.) Bioplate, Inc. The Bioplate® ZIP® Craniotomy Fixation System (K013050)

{1}------------------------------------------------

- (2) Bioplate, Inc.
Device Modification of the Bioplate® ZIP® Craniotomy Fixation System (K020088)

### Description of the Device:

The Bioplate® ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques.

#### Intended Use of the Device:

The Bioplate® ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

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

All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.

K070901 6/15/07.A

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bioplate, Inc. % Mr. Jesus T. Farinas Director, QA/RA 3643 Lenawee Avenue Los Angeles, California 90016-4310

JUN 1 5 2007

Re: K070901

Trade/Device Name: Bioplate® Zip® Craniotomy Fixation System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: II Product Code: GXN Dated: May 17, 2007 Received: May 18, 2007

Dear Mr. Farinas:

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.

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.

{3}------------------------------------------------

Page 2 - Mr. Jesus T. Farinas

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 toll-free number [phone] or [phone] or on the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Breen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):____ K070901

Device Name: Modified plate design for Bioplate® ZIP® Craniotomy Fixation System.

Indications For Use:

The Bioplate® ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Calvare Snelling

Division of General, Restorative, and Neurological Devices

**510(k) Number** K070901

Page 1 of