THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

K013050 · Bioplate, Inc. · GXN · Dec 10, 2001 · Neurology

Device Facts

• Record ID: K013050
• Device Name: THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
• Applicant: Bioplate, Inc.
• Product Code: GXN · Neurology
• Decision Date: Dec 10, 2001
• Decision: SESE
• Submission Type: Traditional
• 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. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Device Story

Bioplate® ZIP™ Craniotomy Fixation System; cranial bone flap fixation device. Consists of two circular titanium alloy (6Al4V) disks in parallel configuration connected by internal serrated post. Used in neurosurgical procedures to reattach bone flap to cranium; aligns and stabilizes bony tissue during healing. Operated by neurosurgeons in OR setting. Single-use implant. Provides mechanical fixation; facilitates bone healing.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Material: 6Al4V titanium alloy. Form factor: Two circular disks (10mm to 18mm diameter) connected by an internal serrated post. Mechanism: Mechanical fixation/clamping. Single-use. Non-active device.

Indications for Use

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

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

• Stryker Instruments Leibinger Quik Disk (K993990)
• Synthes (USA) Cranial Flap Twist Clamp (K991860)
• Synthes (USA) Cranial Flap Tube Clamp (K992000)
• Walter Lorenz Surgical Rapidflap Cranial Clamp (K991029)
• Ikonos Corp. Sevrain Cranial Clamp (K971252)
• Ikonos Corp. Sevrain Cranial Clamp SCC-200 Series (K971408)
• Aesculap, Inc. Aesculap Craniofix Titanium Clamp System (K972332)

Submission Summary (Full Text)

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K013050
page 1 of 2

#### BIOPLATE, INC. 6911 Melrose Ave. Los Angeles, California 90038 Tel: [phone], FAX: [phone]

## 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

The Bioplate® ZIP™ Craniotomy Fixation System

#### Common name

Plate, Cranioplasty, Preformed, Non-Alterable

### Classification name

Plate, Cranioplasty, Preformed, Non-Alterable

## Device Classification

84GXN (21CFR - 882.5330)

#### Predicate Devices

- Stryker Instruments (1) Leibinger Quik Disk K993990
- (2) Synthes (USA) Synthes Cranial Flap Twist Clamp K991860
- (3) Synthes (USA) Synthes Cranial Flap Tube Clamp K992000
- Walter Lorenz Surgical (4) Rapidflap Cranial Clamp K991029

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- (5) Ikonos Corp. Sevrain Cranial Clamp K971252
- Ikonos Corp. (6) Sevrain Cranial Clamp SCC-200 Series K971408
- (7) Aesculap, Inc. Aesculap Craniofix Titanium Clamp System K972332

## Description of the device

The Bioplate® ZIP™ Craniotomy Fixation System consists of two circular disks, in a parallel configuration, that are connected by an internal, serrated post. The devices will be available in several sizes with disk diameters in the range of 10mm to 18mm to be used for varying cranial closure techniques. The implant devices will be manufactured from 6Al4V titanium allov material.

#### Intended used 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. 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 Bioplate® ZIP™ Craniotomy Fixation System has the same indications for use as the predicate devices marketed by Bioplate, Inc. Synthes (USA), Stryker Instruments, Walter Lorenz Surgical, and Aesculap, Inc. All of the technical characteristics of The Bioplate® ZIP™ Craniotomy 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carol E. Jones Bioplate, Inc. 6911 Melrose Avenue Los Angeles, California 90038

Re: K013050

Trade/Device Name: The Bioplate® ZIP™ Craniotomy Fixation System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: September 11, 2001 Received: September 11, 2001

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 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.

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#### Page 2 - Ms. Jones

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to ocg... mainting of substantial equivalence of your device to a legally premits to the are in the President of the 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 II you desire specific advice for you invitro diagnostic devices), please contact the Office of additionally 21 CFR Far 007.10 Additionally, for questions on the promotion and advertising of Complance at [phone] - 1697 - 1697 - 1639. Also, please note the your do roos, pread connect as a reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mionmation currers, 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,

Susan Walker,

Image /page/3/Picture/5 description: The image shows a handwritten letter 'fa' in cursive. The letter is written in black ink on a white background. The 'f' is slightly larger than the 'a', and the two letters are connected.

Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Bioplate Inc. APPLICANT:

510(k) NUMBER: (if known): KO(3050

DEVICE NAME: Bioplate® ZIP™ Craniotomy Fixation System

# INDICATIONS FOR USE:

The Bioplate® ZIP™ Craniotomy Fixation System is intended to reattach a cranial The Bloplate® ZIP™ Cranium after a craniotomy procedure. The device is bone flap to the surrounding crailian and mealing proceacer. Fach device is
used to align and stabilized bony tissue while normal healing on the stire is used to align and stablized borly tissue while normal houling over 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
Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-

(Optional Format 1-2-96)

Susan Walker/

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013050