NORIAN CRS FAST SET PUTTY

K060443 · Synthes (Usa) · GXP · Apr 13, 2006 · Neurology

Device Facts

• Record ID: K060443
• Device Name: NORIAN CRS FAST SET PUTTY
• 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 Fast Set Putty 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 Fast Set Putty 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 Fast Set Putty is a moldable, thermally activated, biocompatible bone cement; supplied as sterile calcium phosphate powder and dilute sodium phosphate solution. Components are mixed manually using a cup and spatula to create a putty; applied by a clinician to craniofacial defects. Material cures in situ to form a composition approximating the mineral phase of bone; gradually remodeled over time. Used for restoration or augmentation of bony contours in the craniofacial skeleton. Benefits patient by providing structural restoration of defects.

Clinical Evidence

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

Technological Characteristics

Calcium phosphate bone cement; supplied as powder and liquid solution; thermally activated; moldable putty consistency; biocompatible; sterile; single-use.

Indications for Use

Indicated 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. Contraindicated for use in the spine or in the presence of active or 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.

Submission Summary (Full Text)

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## K060443

## 3. 510(k) Summary

| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Angela J. Silvestri<br>[phone] |
| Device Name: | Norian CRS Fast Set Putty |
| Device Classification: | 21 CFR 882.5300 - Methyl methacrylate for cranioplasty |
| Device Description: | Norian CRS Fast Set Putty is a moldable, thermally activated,<br>biocompatible bone cement. Norian CRS Fast Set Putty is supplied in<br>two containers: one container holds sterile powder (calcium<br>phosphate) and the second container holds sterile solution (dilute<br>sodium phosphate). When the powder and solution are mixed together<br>with the provided cup and spatula, the resultant putty material is<br>suitable for augmentation and restoration of the craniofacial skeleton.<br>When fully cured, the composition formed closely approximates the<br>mineral phase of bone. Norian CRS Fast Set Putty is gradually<br>remodeled over time. This material is provided sterile and is for<br>single use only. |
| Indications for use: | Norian CRS Fast Set Putty 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>Norian CRS Fast Set Putty is not intended for use in the spine and<br>should not be used in the presence of active or suspected infection. |
| | Predicate Device |
| Substantial Equivalence<br>Determination | This device is equivalent to the predicate in terms of material<br>composition, physical properties, and performance characteristics. |

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APR 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060443

Trade/Device Name: Norian CRS Fast Set Putty 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 10 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 (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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## 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.

. Mall

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

Enclosure

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2. Indications for Use Statement

| Page | 1 of 1 |
|---------------------------|---------------------------|
| 510(k) Number (if known): | |
| Device Name: | Norian CRS Fast Set Putty |
| Indications For Use: | |

Norian CRS Fast Set Putty 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:

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

Over-The-Counter Use Use Prescription × — AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Qgmall

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

K060443 510(k) Number_