SPIN DOWN RAPIDFLAP

K031034 · Walter Lorenz Surgical, Inc. · GXN · May 21, 2003 · Neurology

Device Facts

• Record ID: K031034
• Device Name: SPIN DOWN RAPIDFLAP
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: GXN · Neurology
• Decision Date: May 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Spin Down RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.

Device Story

Spin Down RapidFlap is a cranial fixation device used for re-attaching bone flaps post-craniotomy. It consists of upper and lower plates connected by a threaded stem mechanism. The device is manufactured from CP Titanium and Titanium 6Al 4V alloy and is supplied sterile. It is intended for use by neurosurgeons in a clinical or operating room setting. The device functions by mechanically securing the bone flap to the skull. It provides a similar clinical function to existing cranial clamps, offering a modified attachment mechanism compared to previous grooved-post designs. The device benefits patients by providing stable cranial fixation during the healing process following neurosurgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: CP Titanium and Titanium 6Al 4V alloy. Design: Upper and lower plates with threaded stem attachment. Sterilization: Sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for re-attachment of bone flap following craniotomy. Contraindicated in patients with decompression flaps, active or latent infection, or insufficient bone quantity/quality.

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

• Sevrain Cranial Clamp SCC100 (K971252)
• RapidFlap Cranial Clamp (K991029)

Submission Summary (Full Text)

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MAY 21 2003

K03-1034

page 1 of 1

## Summary of Safety and Effectiveness

Device Modification Name: Spin down rapidflap

| Name of previously cleared 510(k): | Sevrain Cranial Clamp SCC100 - 510(k) K971252 |
|------------------------------------|-----------------------------------------------|
| | RapidFlap Cranial Clamp - 51k(k) K9910229 |

Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable

Product Code and Reference: 84 GXN (21 CFR - 882.5330)

Intended use: Spin Down RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.

## Device Modification Description:

| | Spin Down RapidFlap<br>modification | K971252 Sevrain<br>Cranial Clamp | K991029 RapidFlap<br>Cranial Clamp |
|--------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------|
| Attachment of<br>upper and lower<br>plates | Threaded stem<br>attachment between<br>the upper and lower<br>plates | Threaded stem<br>attachment between<br>upper and lower plates | Grooved post<br>connection between<br>the upper and lower<br>plates. |
| Material | CP Titanium and<br>Titanium 6A1 4V alloy | CP Titanium, grade 2 | Titanium 6A1 4V alloy |
| Sterility | Sterile | Non-Sterile | Sterile |

## Potential Risks:

The potential risks associated with the Spin Down RapidFlap are the same as with the Sevrain Cranial Clamp (K971252), SCC-100 and RapidFlap Cranial Clamp (K991029). The following are contraindicated in the package insert:

- 1. Patients with a decompression flap.
- 2. Active infection or latent infection.
- 3. Patient with insufficient quantity or quality of bone.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.

Public Health Service

MAY 21 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kim Reed Senior Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218-2480

Re: K031034

Trade/Device Name: Spin Down RapidFlap Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: II Product Code: GXN Dated: March 31, 2003 Received: April 1, 2003

Dear Ms. Reed:

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 misbrarding 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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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,

Mark N Milken

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): (03-103

Spin down rapidflap Device Name:

Indications For Use:

Spin Down RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Milker
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K031034

Prescription Use (Per 21 CFR 801.109) OR

510(k) Number -

Over-The-Counter Use __

(Optional Format 1-2-96)

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