STRYKER LEIBINGER CRANIAL FIXATION SYSTEM

K030378 · Stryker Instruments · GXN · Mar 20, 2003 · Neurology

Device Facts

• Record ID: K030378
• Device Name: STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
• Applicant: Stryker Instruments
• Product Code: GXN · Neurology
• Decision Date: Mar 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Leibinger Cranial Fixation System is intended for the fixation of a cranial bone flap after a craniotomy. The implant could be applied in the craniotomy gap as well as in burr holes.

Device Story

Stryker Leibinger Cranial Fixation System consists of implants designed for securing cranial bone flaps following craniotomy procedures. The system is utilized by neurosurgeons in an operating room setting to stabilize bone flaps within the craniotomy gap or burr holes. By providing mechanical fixation, the device restores cranial integrity, facilitating proper bone healing and protecting underlying neural structures. The system functions as a mechanical implant; it does not involve electronic inputs, software, or automated processing.

Clinical Evidence

bench testing only

Technological Characteristics

Mechanical cranial fixation system. Materials and specific dimensions are not detailed in the provided text. The device is a non-active, implantable mechanical fastener system. No software, energy source, or connectivity features.

Indications for Use

Indicated for patients undergoing craniotomy requiring fixation of the cranial bone flap, including application in the craniotomy gap and burr holes.

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

• Leibinger Quik Disk Titanium Clamp System (K993990)
• Aesculap Craniofix Titanium Clamp System (K972332)
• Synthes Cranial Flap Twist Clamp (K991860)
• Walter Lorenz RapidFlap Cranial Clamp (K991029)

Submission Summary (Full Text)

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030378
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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:

Stryker Leibinger Cranial Fixation System

| General Information | | | | |
|--------------------------------|------------------------------------------------------------------------------------------|--|--|-------------|
| Proprietary Name: | Stryker Leibinger Cranial Fixation System | | | |
| Common Name: | Plate, Cranioplasty, Pre-formed, Non-Alterable | | | |
| Proposed Regulatory Class: | Class II | | | MAR 20 2003 |
| Device Classification: | GXN<br>882.5330, Plate, Cranioplasty, Preformed, Non- Alterable | | | |
| Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>269-323-4226 | | | |
| Submitter's Registration #: | 1811755 | | | |
| Manufacturer's Registration #: | 8010177 | | | |
| Contact Person: | Wade T. Rutkoskie<br>Associate Manager RA QA<br>Phone: [phone]<br>Fax: [phone] | | | |

## Intended Use

The Stryker Leibinger Cranial Fixation System is intended for the fixation of a cranial bone flap after a craniotomy. The implant could be applied in the craniotomy gap as well as in burr holes.

## Substantial Equivalence

EQUIVALENT PRODUCTS:

The Stryker Leibinger Cranial Fixation System is substantially equivalent to the Leibinger Quik Disk Titanium Clamp System (K993990), Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter Lorenz RapidFlap Cranial Clamp (K991029).

Wude T. Rutterskiel

Wade T. Rutkoskie Associate Manager RA QA Stryker Instruments Leibinger Division

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2003

Mr. Wade T. Rutkoskie Associate Manager RA QA Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49087

Re: K030378

Trade/Device Name: Stryker® Leibinger Cranial Fixation System Regulation Number: 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: II Product Code: GXN Dated: February 4, 2003 Received: February 5, 2003

Dear Mr. Rutkoskie:

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. Iisting 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. Wade T. Rutkoskie

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,

R. Mark N. Millham

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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510(k) Number (if known):___

Device Name: Stryker® Leibinger Cranial Fixation System

Indication For Use:

The Stryker® Leibinger Cranial Fixation System is intended for the fixation of a cranial bone flap after a craniotomy. The implant could be applied in the craniotomy gap as well as in burr holes.

KO.303

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Concurrence of CDRH, Office of device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use Or

(Optional Format 1-2-96)

for Mark N. Milkerson

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