SYNTHES CRANIAL FLAP TUBE CLAMP

K992000 · Synthes (Usa) · GXN · Jul 20, 1999 · Neurology

Device Facts

• Record ID: K992000
• Device Name: SYNTHES CRANIAL FLAP TUBE CLAMP
• Applicant: Synthes (Usa)
• Product Code: GXN · Neurology
• Decision Date: Jul 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Cranial Flap Tube Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.

Device Story

Synthes Cranial Flap Tube Clamp consists of two clamp discs connected by a central clamp shaft; disc diameters range from 8.0 mm to 20 mm. Device is used by surgeons in a clinical setting to mechanically reattach a cranial bone flap to the surrounding cranium following a craniotomy. Device is MRI safe and for single use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparison to the predicate device.

Technological Characteristics

Mechanical fixation device consisting of two discs and a connecting shaft. Dimensions: 8.0 mm to 20 mm disc diameter. MRI safe. Single-use.

Indications for Use

Indicated for patients undergoing craniotomy procedures requiring reattachment of a cranial bone flap to the surrounding cranium.

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's Craniofix Titanium Clamp System

Submission Summary (Full Text)

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99200

JUL 20 1999

Attachment VII:

SUBMITTER

DEVICE NAME:

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

Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone]

Contact: Sheri L. Musgnung

Fastener, Plate, Cranioplasty

Plate, Cranioplasty, Preformed, Alterable;

Class II, 21 CFR 882.5320 and 882.5360

Synthes Cranial Flap Tube Clamp

COMMON OR USUAL NAME

DEVICE CLASSIFICATION:

Aesculap's Craniofix Titanium Clamp System PREDICATE DEVICE:

DESCRIPTION:

INTENDED USE:

Synthes Cranial Flap Tube Clamp consists of two clamp discs with a clamp shaft in between the discs. The disc diameters range between 8.0 mm to 20 mm. The Cranial Flap Tube Clamp is MRI safe and is for single use only.

Synthes Cranial Flap Tube Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.

CONFIDENTIAL

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 1999

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

K992000 Re:

> Trade Name: Synthes Cranial Flap Tube Clamp Regulatory Class: II Product Code: GXN Dated: June 9, 1999 Received: June 15, 1999

Dear Ms. Musgnung:

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 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 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 (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 requirement, 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. Sheri L. Musgnung

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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement 2.0

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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|---------------------------------|
| 510(k) Number (if known): | 5992000 |
| Device Name: | Synthes Cranial Flap Tube Clamp |

Indications For Use:

Synthes Cranial Flap Tube Clamp 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)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

tasley

(Division Sign-Off)
Division of General Restorative Devices K992000
510(k) Number

Synthes (USA) Cranial Flap Tube Clamp CONFIDENTIAL