RESORBABLE CRANIAL CLAMPS

K021408 · Synthes (Usa) · GXR · Jul 29, 2002 · Neurology

Device Facts

• Record ID: K021408
• Device Name: RESORBABLE CRANIAL CLAMPS
• Applicant: Synthes (Usa)
• Product Code: GXR · Neurology
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Resorbable Cranial Clamps are intended for covering burr holes and for fixation of cranial bone flaps.

Device Story

Resorbable Cranial Clamps consist of two disks connected by a ratcheting shaft, with an optional spacer. Device used for covering burr holes and securing cranial bone flaps following neurosurgical procedures. Mechanical fixation achieved via ratcheting mechanism. Resorbable material allows for gradual degradation post-implantation. Used by neurosurgeons in clinical/OR settings.

Clinical Evidence

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

Technological Characteristics

Material: Poly(L/DL-lactide). Design: Two disks connected by a ratcheting shaft with optional spacer. Mechanical fixation device.

Indications for Use

Indicated for covering burr holes and fixation of cranial bone flaps in patients undergoing cranial surgery.

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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Page 1 of 1

'JUL 2 9 2002

K021408

### Summary of Safety and Effectiveness Information [510(k) Summary] 3.0

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] ext. 7191<br>Contact: Matthew M. Hull |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Resorbable Cranial Clamps |
| CLASSIFICATION: | Class II, 21 CFR 882.5250: Burr Hole Cover and 882.5360: Cranioplasty<br>Plate Fastener. |
| PREDICATE DEVICE: | Documentation was provided which demonstrated the Synthes Resorbable<br>Cranial Clamp to be substantially equivalent to other legally marketed<br>devices. |
| DEVICE DESCRIPTION: | Resorbable Cranial Clamps consist of two disks connected by a ratcheting<br>shaft with an available optional spacer. |
| INTENDED USE: | Resorbable Cranial Clamps are intended for covering burr holes and for<br>fixation of cranial bone flaps. |
| MATERIAL: | Poly(L/DL-lactide) |

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 9 2002

Mr. Matthew M. Hull, RAC Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K021408

Trade/Device Name: Synthes Resorbable Cranial Clamps Regulation Number: 882.5250 and 882.5360 Regulation Name: Burr Hole Cover and Cranioplasty Plate Fastener Regulatory Class: Class II Product Code: GXR Dated: May 2, 2002 Received: May 3, 2002

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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Page 2 - Mr. Matthew M. Hull, RAC

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

R. Mark N. Millikan

elia 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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#### 2.0 Indications for Use Statement

510(k) Number (if known):

K021408

Device Name: Resorbable Cranial Clamps

Indications for Use:

Synthes Resorbable Cranial Clamps are intended for covering burr holes and for fixation of cranial bone flaps.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use NB

L. Mark N. Millman

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

510(k) Number K021408

Confidential