AESCULAP PEEK CRANIOFIX

K091692 · Aesculap, Inc. · GXR · Aug 12, 2010 · Neurology

Device Facts

• Record ID: K091692
• Device Name: AESCULAP PEEK CRANIOFIX
• Applicant: Aesculap, Inc.
• Product Code: GXR · Neurology
• Decision Date: Aug 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.

Device Story

Aesculap PEEK CranioFix is a cranial fixation device consisting of two PEEK discs connected by a suture loop. Used by neurosurgeons in an operating room setting to secure bone flaps following craniotomy. The device provides mechanical stabilization of the bone flap to the surrounding cranium. It is a passive implantable device; no software, electronics, or algorithms are involved.

Clinical Evidence

No clinical data. Bench testing only; device evaluated for performance in accordance with ASTM F452 and ASTM F2026.

Technological Characteristics

Material: PEEK (Polyetheretherketone). Design: Two discs connected by a suture loop. Standards: ASTM F452, ASTM F2026. Passive implantable device. No software or energy source.

Indications for Use

Indicated for fixation of cranial bone flaps in patients undergoing cranial surgery.

Regulatory Classification

Identification

A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

Predicate Devices

• Aesculap Absorbable Craniofix (K040080)

Submission Summary (Full Text)

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# K091692

Page 1 of 2

#### 510(k) SUMMARY (as required by 21 CFR 807.92) B.

| Aesculap PEEK Craniofix |
|-------------------------|
| August 10, 2010 |

AUG 1 2 2010

Aesculap® Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714

Lisa M. Bovle CONTACT: 800-258-1946 (phone) 610-791-6882 (fax)

Aesculap PEEK CranioFix TRADE NAME:

Burr Hole Cover COMMON NAME:

CLASSIFICATION NAME: Cover, Burr, Hole (GXR)

REGULATION NUMBER: 882.5250

### SUBSTANTIAL EQUIVALENCE

The Aesculap PEEK CranioFix as described in this premarket notification is substantially equivalent to the following predicate device:

- Aesculap Absorbable Craniofix (K040080)
## DEVICE DESCRIPTION

ﺳﯿﺮ

Aesculap's PEEK CranioFix consists of two absorbable discs connected by a suture loop.

#### INDICATIONS FOR USE

Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.

#### TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}

The Aesculap PEEK Craniofix has similar characteristics in design features (size, shape, function) and is considered substantially equivalent to the previously cleared predicate device on the market (K040080). The only change to the new device when compared to the predicate is a change in material.

All materials used in the manufacturing of the PEEK Craniofix are well recognized in their use as being biocompatible materials for implants and have been used in surgical procedures for many years. These materials have been accepted in previously cleared submissions.

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091692

# PERFORMANCE DATA

. . .

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. This device has been evaluated and performs in accordance with ASTM F452/ASTM F2026. The subject device was found to be similar in performance to previously cleared spinal systems with similar indications.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Aesculap®, Inc. c/o Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034

AUG 1 2 2010

Re: K091692

Trade/Device Name: Aesculap PEEK CranioFix Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: June 14, 2010 Received: June 15, 2010

Dear Ms. Boyle:

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, Or to 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 misbrandi, ing and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Lisa M. Boyle

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 af 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elections product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115800.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 305 Almin ase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR) Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofire no [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kesia Alexander

Image /page/3/Picture/8 description: The image shows the word "for" written in cursive. The "f" is large and loops around, connecting to the "o" and "r". The writing appears to be handwritten, possibly with a pen or marker. The word is positioned on the left side of the image.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K091692 PEEK CranioFix

AUG 1 2 2010

#### INDICATIONS FOR USE STATEMENT A.

**510(k) Number (if known):** K091692

Device Name: PEEK CranioFix

Indication for Use:

Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.

Over-the-Counter Use Prescription Use or

(per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

(Optional Format 3-10-98)

510(k) Number K091692

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