CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM

K071138 · Prosurg, Inc. · GXR · Aug 15, 2007 · Neurology

Device Facts

• Record ID: K071138
• Device Name: CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
• Applicant: Prosurg, Inc.
• Product Code: GXR · Neurology
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System is intended for use in covering burr holes and for fixation of cranial bone flaps after craniotomy

Device Story

CranioClamp™ is a bioabsorbable fixation system designed for cranial bone flap stabilization and burr hole coverage following craniotomy. The device provides mechanical securement of the bone flap to the surrounding cranium. It is intended for use by neurosurgeons in an operating room setting. By utilizing bioabsorbable materials, the system eliminates the need for permanent metallic implants, potentially reducing long-term complications associated with foreign body presence in the cranium. The device is applied during the closure phase of the surgical procedure to restore cranial integrity.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing.

Technological Characteristics

Bioabsorbable material construction; mechanical fixation mechanism for cranial bone flaps; burr hole cover form factor; sterile, single-use device.

Indications for Use

Indicated for patients undergoing craniotomy requiring burr hole coverage and cranial bone flap fixation.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 15 2007

Prosurg, Inc c/o Mr. Ashvin Desai 2193 Trade Zone Blvd San Jose CA 95131

AUG 15 2007

Re: K071138 Trade/Device Name: CranioClamp™ - Bioabsorbable Cranial Bone Flap Fixation System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr hole cover Regulatory Class: Class II Product Code: GXR, HBW Dated: July 30, 2007 Received: August 2, 2007

Dear Mr. Desai:

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 -- Mr. Ashvin Desai

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.

ff 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Bonellin

Mark N. Melkerson 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

510(k) Number (if known): K071138

CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System Device Name:

Indications For Use:

The CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System is intended for use in covering burr holes and for fixation of cranial bone flaps after craniotomy

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

Over-The-Counter Use No (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)

Barbara Buehrle

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Division of General, Restorative, and Neurological Devices

**510(k) Number** K071138