NORIAN CRS BONE CEMENT

K060445 · Synthes (Usa) · GXP · Apr 13, 2006 · Neurology

Device Facts

• Record ID: K060445
• Device Name: NORIAN CRS BONE CEMENT
• Applicant: Synthes (Usa)
• Product Code: GXP · Neurology
• Decision Date: Apr 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Norian CRS Bone Cement is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2. Norian CRS Bone Cement is not intended for use in the spine and should not be used in the presence of active or suspected infection.

Device Story

Norian CRS Bone Cement is an injectable, moldable, biocompatible calcium phosphate bone cement. Reactants pack contains sterile powder and dilute sodium phosphate solution. Components mixed in reusable mixer to form viscous paste; remains injectable for ~5 minutes at 18-23°C. Hardens at body temperature (37°C) within 10 minutes. Material is slowly resorbed and replaced by bone over years. Intended for single use in craniofacial applications. Used by clinicians to fill/augment bony contours.

Clinical Evidence

No clinical data provided; substantial equivalence based on material composition and physical/performance characteristics.

Technological Characteristics

Calcium phosphate bone cement; injectable/moldable paste. Components: sterile powder and dilute sodium phosphate solution. Sets at body temperature (37°C). Biocompatible, resorbable material.

Indications for Use

Indicated for filling craniofacial defects (e.g., burr hole voids) in the restoration or augmentation of bony contours of the craniofacial skeleton (fronto-orbital, malar, mental areas) with surface area ≤ 25cm2. Contraindicated for spinal use or in presence of active/suspected infection.

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• Norian CRS Bone Cement (K973789)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the upper right of the word.

## 3. 510(k) Summary

| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Angela Silvestri<br>Synthes (USA)<br>1230 Wilson Drive<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Norian CRS Bone Cement |
| Device Classification: | 21 CFR 882.5300 - Methyl methacrylate for cranioplasty |
| Device Description: | Norian CRS Bone Cement is an injectable, moldable, and<br>biocompatible bone cement. The Reactants Pack contains sterile<br>powder (calcium phosphate) and a syringe that contains sterile<br>solution (dilute sodium phosphate). The Reactants Pack is designed to<br>be placed in a reusable mixer where the 2 components are mixed<br>together to form a smooth, viscous paste that remains injectable for<br>approximately 5 minutes at 18 -23°C / 64°- 73°F. At body temperature<br>(37°C / 98.6°F), Norian CRS Cement begins to harden after 2 minutes<br>and sets in approximately 10 minutes. Norian CRS Cement is slowly<br>resorbed and replaced by bone over a period of years. This material is<br>provided sterile and is for single use only. |
| Indications for use: | Norian CRS Bone Cement is intended for filling craniofacial defects<br>in the restoration or augmentation of bony contours of the craniofacial<br>skeleton (including fronto-orbital, malar, and mental areas) such as<br>burr hole voids and other craniofacial defects, with a surface area no<br>larger than 25cm2.<br><br>Norian CRS Bone Cement is not intended for use in the spine and<br>should not be used in the presence of active or suspected infection. |
| Predicate Device | Norian CRS Bone Cement K973789 |
| Substantial Equivalence<br>Determination | This device is equivalent to the predicate in terms of material<br>composition, physical properties and performance characteristics. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol on the right, which is a staff with two snakes entwined around it. To the left of the caduceus, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern.

Public Health Service

APR 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synthes (USA) c/o Ms. Angel Silvestri Group Manager, Regulatory Affairs 1230 Wilson Drive West Chester, Pennsylvania 19380

Re: K060445

Trade/Device Name: Norian CRS Bone Cement Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: February 16, 2006 Received: February 23, 2006

Dear Ms. Silvestri:

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 misbranding 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

## Page 2 - Ms. Angel Silvestri

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/industry/support/index.html.

Sincerely vours.

eMell

Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. There is a horizontal line underneath the word and logo.

## 2. Indications for Use Statement

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __________ Norian CRS Bone Cement

Indications For Use:

Norian CRS Bone Cement is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm ..

Contraindications:

Norian CRS Bone Cement is not intended for use in the spine and should not be used in the presence of active or suspected infection.

Use Prescription X - AND/OR (Part 21 CFR 801 Subpart D) ·

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number_ K060445