RAPIDFLAP CRANIAL CLAMP

K991029 · Walter Lorenz Surgical, Inc. · GXN · Apr 23, 1999 · Neurology

Device Facts

• Record ID: K991029
• Device Name: RAPIDFLAP CRANIAL CLAMP
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: GXN · Neurology
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

RapidFlap Cranial Clamp is a surgical fixation device used for re-attaching bone flaps after craniotomy. It consists of upper and lower plates connected by a grooved post mechanism. The device is manufactured from titanium 6 Al 4 V alloy and is supplied sterile. It is intended for use by neurosurgeons in an operating room setting. The device provides mechanical stabilization of the bone flap to the cranium. It is not designed for pediatric use or for patients requiring future reoperation due to unknown long-term removability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium 6 Al 4 V alloy. Design: Upper and lower plates with grooved post connection. Sterilization: Provided sterile. Energy source: None (mechanical fixation).

Indications for Use

Indicated for re-attachment of bone flap following craniotomy. Contraindicated in patients with decompression flaps, active infection, blood supply limitations, insufficient bone quantity, latent infection, mental/neurologic conditions preventing adherence to postoperative care, or foreign body sensitivity. Not for pediatric neurosurgery or patients likely to require reoperation.

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)

Submission Summary (Full Text)

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4/23/99

## Summary of Safety and Effectiveness

Device Modification Name: RapidFlap Cranial Clamp

Name of previously cleared 510(k): Sevrain Cranial Clamp SCC100 - 510(k) K971252

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

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

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

Device Modification Description: The modification to the SCC-100 device are as follows:

## 1. Attachment of upper and lower plates

- SCC-100 identified a threaded stem attachment between the upper and lower plates .
- · Modified RapidFlap device has a grooved post connection between the upper and lower plates.
- 2. The material
- SCC-100 identifies commercially pure titanium, grade 2 material ●
- Modified RapidFlap device is manufactured from titanium 6 Al 4 V alloy. .
- 3. Sterility
- SCC-100 device is nonsterile .
- Modified RapidFlap device will be marketed sterile (details described under . sterility information).
- 4. Drawings for necessary instrumentation changes for application of modified device is included in Attachment I.

## Potential Risks:

The potential risks associated with the RapidFlap are the same as with the Sevrain Cranial Clamp, SCC-100. The following are contraindicated in the package insert:

- 1. Patients with a decompression flap.
- 2. Active infection.
- 3. Patient conditions including, blood supply limitation, insufficient quantity of bone, or latent infection.
- 4. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- 5. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
- 6. RapidFlap device has not been designed for use in pediatric neurosurgery. The effect of skull growth on retention is unknown.
- 7. Not intended for use in patients likely to require reoperation. This device has not been demonstrated clinically to be removable after long term implantation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Ms. Diana Preston Requlatory Affairs Specialist Walter Lorenz Surqical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K991029 Trade Name: RapidFlap Cranial Clamp Requlatory Class: II Product Code: GXN March 26, 1999 Dated: March 29, 1999 Received:

Dear Ms. Preston:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, 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 requlation (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 requlations.

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Page 2 - Ms. Diana Preston

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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510(k) Number (if known): unknown

RapidFlap Cranial Clamp Device Name:

RapidFlap is indicated for the re-attachment of the bone flap after a Indications For Use: craniotomy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Acoela

(Division S Division orative Devices 510(k) Nun

Prescription Use >> (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)