SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP

K041611 · Synthes (Usa) · GXR · Sep 8, 2004 · Neurology

Device Facts

• Record ID: K041611
• Device Name: SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
• Applicant: Synthes (Usa)
• Product Code: GXR · Neurology
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5250
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Synthes Rapid Resorbable Cranial Clamp is intended for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations.

Device Story

Synthes Rapid Resorbable Cranial Clamp consists of two disks connected by a tensioned ratcheting shaft. Device fits range of burr holes and craniotomy gap sizes. Used by surgeons for cranial bone flap fixation and burr hole coverage. Mechanical design provides secure closure of cranial defects.

Clinical Evidence

No clinical data provided; substantial equivalence based on documentation of design and intended use.

Technological Characteristics

Resorbable cranial clamp consisting of two disks connected by a tensioned ratcheting shaft. Designed for burr hole coverage and cranial bone flap fixation.

Indications for Use

Indicated for covering burr holes and fixation of cranial bone flaps in adult and pediatric populations.

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
• Biomet Lactosorb RapidFlap

Submission Summary (Full Text)

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510(k) Summary

3.0

SEP = 8 2004

K 041611

Page _________ of ____

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Class II, §882.5250 - Burr hole cover<br>Class II, §882.5360 - Cranioplasty plate fastener |
| Classification: | Title 21 CFR 882.5250: Burr Hole Cover and section 882.5360:<br>Cranioplasty Plate Fastener. |
| Predicate Device: | Synthes Resorbable Cranial Clamp<br>Biomet Lactosorb RapidFlap |
| Device Description: | Synthes Rapid Resorbable Cranial Clamp consists of two disks<br>connected by a tensioned ratcheting shaft. The clamps fit a range<br>of burr holes and craniotomy gap sizes. |
| Intended Use: | Synthes Rapid Resorbable Cranial Clamp is intended for covering<br>burr holes and for fixation of cranial bone flaps in adult and<br>pediatric populations. |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the Synthes<br>Rapid Resorbable Cranial Clamp to be substantially equivalent to<br>other legally marketed devices. |
| | The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Federal Food, Drug and Cosmetic Act, as amended<br>and as applied under 21CFR 807, Subpart E under which a device<br>can be marketed without premarket approval or reclassification. A<br>determination of substantial equivalency under this notification is<br>not intended to have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence<br>herein shall be construed as an admission against interest under the<br>US Patent Laws or their application by the courts. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli. Pennsylvania 19301

Re: K041611

Trade/Device Name: Rapid Resorbable Cranial Clamp Regulation Number: 21 CFR 882.5250, 21 CFR 882.5360 Regulation Name: Burr hole cover, Cranioplasty plate fastener Regulatory Class: II Product Code: GXR, HBW Dated: June 14, 2004 Received: June 15, 2004

Dear Ms. Boyle:

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. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and the FDA finding of substantial equivalence of your device to a legally promated 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 may be obtained 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,

Sincerely yours,

Mark A. Milken

Celia M. Witten, PhD, MD Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0

Indications for Use

(041611

Rapid Resorbable Cranial Clamp

510(k) Number (if known):

Device Name:

Indications for Use:

Synthes Rapid Resorbable Cranial Clamp is indicated for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations.

Prescription Use
(Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

Jse
rt C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulkerson

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

**510(k) Number** K041611