AESCULAP ABSORBABLE CRANIOFIX

K040080 · Aesculap, Inc. · GXR · Mar 31, 2004 · Neurology

Device Facts

• Record ID: K040080
• Device Name: AESCULAP ABSORBABLE CRANIOFIX
• Applicant: Aesculap, Inc.
• Product Code: GXR · Neurology
• Decision Date: Mar 31, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aesculap's Absorbable CranioFix is intended for fixation of cranial bone flaps.

Device Story

Aesculap Absorbable CranioFix is a cranial bone flap fixation device. It consists of two absorbable discs connected by a suture loop. The device is used by neurosurgeons during craniotomy procedures to secure bone flaps back into position. It functions as a mechanical fastener to provide stability to the bone flap during the healing process. The device is intended for use in a clinical/surgical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and performance characteristics.

Technological Characteristics

Absorbable material construction; consists of two discs connected by a suture loop; mechanical fixation principle; sterile.

Indications for Use

Indicated for fixation of cranial bone flaps in patients undergoing craniotomy procedures.

Regulatory Classification

Identification

A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

Predicate Devices

• Synthes Resorbable Cranial Clamp (modified) (K031654)
• Synthes Resorbable Cranial Clamp (K021408 and K031654)
• MacroPore CraniLoc NS (K002334)

Submission Summary (Full Text)

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# MAR 3 1 2004

K040080 Paige
Absorbable CranioFix

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull, Regulatory Affairs Manager<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Aesculap Absorbable CranioFix |
| COMMON NAME: | Cranioplasty plate fastener |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE:<br>REGULATION: | HBW<br>882 5360 |

REVIEW PANEL: Neurology

#### INTENDED USE

Aesculap's Absorbable CranioFix is intended for fixation of cranial bone flaps.

#### DEVICE DESCRIPTION

Aesculap's Absorbable CranioFix consists of two absorbable discs connected by a suture loop.

#### PURPOSE FOR SUBMISSION

The purpose for this submission is to gain marketing clearance for the Aesculap Absorbable CranioFix.

#### PERFORMANCE STANDARDS

No performance standards have been promulgated under Section 514 of the Food, Druq and Cosmetic Act for these devices.

#### SUBSTANTIAL EQUIVALENCE

The Aesculap Absorbable CranioFix as described in this premarket notification is substantially equivalent to these predicate devices:

- Synthes Resorbable Cranial Clamp (modified) (K031654) .
- Synthes Resorbable Cranial Clamp (K021408 and K031654) .
- MacroPore CraniLoc NS (K002334) ◆

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2004

Mr. Matthew M. Hull Regulatory Affairs Manager Aesculap. Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K040080

Trade/Device Name: Aesculap Absorbable CranioFix Regulation Number: 21 CFR 882.5250 Regulation Name: Burr hole cover Regulatory Class: II Product Code: GXR Dated: January 14, 2004 Received: January 15, 2004

Dear Mr. Hull:

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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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/dsma/dsmamain.html

Sincerely yours.

b. Mark N. Mellman

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

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K040080

Device Name: Absorbable CranioFix

X

Indication for Use:

Aesculap's Absorbable CranioFix is intended for fixation of cranial bone flaps.

or

Prescription Use

Over-the-Counter Use

(per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mule N Milken

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

(Optional Format 3-10-98)

510(k) Number K040080

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