LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM

K993990 · Stryker Instruments · GXN · Feb 22, 2000 · Neurology

Device Facts

• Record ID: K993990
• Device Name: LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
• Applicant: Stryker Instruments
• Product Code: GXN · Neurology
• Decision Date: Feb 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Leibinger Quik Disk Titanium Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

Device Story

The Leibinger Quik Disk Titanium Clamp System is a two-piece titanium implant used for cranial flap fixation following craniotomy. It serves as an alternative to traditional bone plates and screws. The device consists of two parallel 15 mm diameter titanium disks connected by an internal, serrated breakaway stem and a grasping clamp assembly contained between the disks. It is used in a surgical setting by neurosurgeons to secure the bone flap to the surrounding cranium. The system includes associated nonpowered neurosurgical instruments for application. By providing a mechanical clamping mechanism, it facilitates stable reattachment of the bone flap, potentially reducing operative time compared to conventional fixation methods.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Titanium. Form factor: Two-piece system with two 15 mm diameter disks connected by a serrated breakaway stem and internal grasping clamp. Energy source: None (nonpowered). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for reattachment of cranial bone flaps to the surrounding cranium following craniotomy procedures in patients requiring cranial fixation.

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

• 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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# FEB 2 2 2003

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS: LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM

#### General Information

| Proprietary Name: | Leibinger Quik Disk Titanium Clamp System |
|--------------------------------|---------------------------------------------------------------------------------------------------------|
| Common Name: | Plate, Cranioplasty, Preformed, Non-Alterable |
| Classification Name(s): | Plate, Cranioplasty, Preformed, Non-Alterable |
| Classification Code(s): | GXN, 882.5330 |
| Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>800-253-7370 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 1811755 |
| Contact Person: | Kristyn R. Kelley<br>Project Engineer<br>Quality Assurance and Regulatory Affairs<br>800-253-7370 x5045 |
| Summary Preparation Date: | November 23, 1999 |

#### Device Description

The Leibinger Quik Disk Titanium Clamp System consists of a two-piece titanium implant and associated nonpowered neurosurgical instruments. The system allows for timely fixation of cranial flaps to the surrounding cranium after craniotomies in lieu of bone plate and screw methods. The Quik Disk has two parallel 15 mm diameter titanium disks that are connected by an internal, serrated breakaway stem and grasping clamp assembly that is fully contained between the two discs.

#### Intended Use

The Leibinqer Quik Disk Titanium Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

#### Substantial Equivalence

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

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## FEB 2 2 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristyn R. Kelley Project Engineer Quality Assurance and Regulatory Affairs Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K993990

Trade Name: Leibinger Quik Disk Titanium Clamp System Regulatory Class: II Product Code: GXN Dated: November 23, 1999 Received: November 24, 1999

Dear Ms. Kelley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Kristyn R. Kelley

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Rill and Wife

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Page_1___ of _________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Leibinger Quik Disk Titanium Clamp System Device Name:

Indications For Use:

: 上一篇:

The Leibinger Quik Disk Titanium Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K993990 |

| Prescription Use | X | OR | Over-The- Counter Use |
|----------------------|---|----|-----------------------|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)