NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY

K102018 · Synthes USA Products, LLC · GXP · Sep 23, 2010 · Neurology

Device Facts

• Record ID: K102018
• Device Name: NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
• Applicant: Synthes USA Products, LLC
• Product Code: GXP · Neurology
• Decision Date: Sep 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm2. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including fronto-orbital areas) such as burr hole voids and other cranial defects.

Device Story

Norian Reinforced and Norian Reinforced Fast Set Putty are moldable, biocompatible bone cements containing reinforcing fibers; intended for craniofacial defect repair/augmentation. Norian Reinforced is an injectable paste mixed via automatic mixer; Fast Set Putty is manually mixed with cup and spatula. Both materials harden at body temperature (37°C) to form a mineral phase approximating bone; slowly resorbed and replaced by bone over years. Used in clinical settings for cranial skeleton reconstruction. Clinicians apply material to fill defects or augment contours; provides structural support during healing. Resists cracking during setting process.

Clinical Evidence

No clinical data. Substantial equivalence supported by mechanical and in vitro comparative testing demonstrating performance equivalent to predicate devices. Biocompatibility testing conducted in accordance with ISO 10993 standards.

Technological Characteristics

Moldable bone cement with reinforcing fibers. Hardens at 37°C. Biocompatibility per ISO 10993. Delivery forms: injectable paste (automatic mixer) or manual putty (cup/spatula).

Indications for Use

Indicated for patients requiring repair or filling of cranial defects and craniotomy cuts (≤ 25 cm2) or restoration/augmentation of cranial skeleton bony contours, including burr hole voids and fronto-orbital areas.

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 (973789)
• Norian CRS Fast Set Putty (K012589)

Submission Summary (Full Text)

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| 510(k) Summary | K102018 | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---------|
| Sponsor: | Synthes Biomaterials<br>1230 Wilson Drive<br>West Chester, PA 19380 | | |
| Company<br>Contact | Jeffrey L. Dow, JD<br>Director, Clinical & Regulatory Affairs<br>Synthes Biomaterials<br>484 356 9720<br>[e-mail] | SEP | 23 2010 |
| Date Summary<br>Prepared | August 25, 2010 | | |
| Device Name: | Norian Reinforced™ and Norian Reinforced Fast Set Putty™ | | |
| Classification: | Class II, 21 CFR §882.5300<br>Methyl Methacrylate for Cranioplasty | | |
| Product Code | GXP | | |
| Predicate<br>Devices: | Norian CRS Bone Cement (973789)<br>Norian CRS Fast Set Putty (K012589) | | |
| Device<br>Description: | Norian Reinforced and Norian Reinforced Fast Set Putty<br>(FSP) are moldable, biocompatible bone cements with added<br>reinforcing fibers. Norian Reinforced and Norian Reinforced<br>FSP are intended for filling craniofacial defects in the<br>restoration or augmentation of bony contours of the<br>craniofacial skeleton. The material resists cracking during the<br>setting process. When fully cured, the composition formed<br>closely approximates the mineral phase of bone. | | |
| | The product is available in two delivery forms. Norian<br>Reinforced is an injectable paste that is mixed with an<br>automatic mixer, and Norian Reinforced Fast Set Putty is<br>manually mixed with a cup and spatula. | | |
| | Norian Reinforced is provided in a sterile pouch ("Rotary<br>Pouch"). The Rotary Pouch is constructed of a clear-film<br>outer pouch and a foil laminate inner pouch with an attached<br>delivery syringe. The Rotary Pouch contains sterile powderpurpose of adding the mixing solution to the pouch. The<br>mixing solution is contained in the Solution Syringe that is | | |

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The Rotary Pouch is designed to be placed in an automatic reusable mixer outside the sterile field where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Reinforced begins to harden after 2 minutes and sets in approximately 10 minutes.

Norian Reinforced is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Reinforced Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the solution syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Reinforced Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Reinforced Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.

The results from mechanical and in vitro comparative testing demonstrate that Norian Reinforced Products are equivalent to the predicate Norian products previously identified. The material has been tested for safety following the biocompatibility standards set forth in ISO 10993. This testing demonstrates that Norian Reinforced Products pass the relevant tests specified, as did the predicates.

Intended Use:

Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm2. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including fronto-orbital areas) such as burr hole voids and other cranial defects.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

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

Synthes Biomaterials c/o Jeffrey L. Dow, JD Director, Regulatory & Clinical Affairs 1230 Wilson Drive West Chester, PA 19380

SEP 2 3 2010

Re: K102018

R102016
Trade/Device Name: Norian Reinforced™ and Norian Reinforced Fast Set PuttyTM Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: GXP Dated: July 14, 2010 Received: July 19, 2010

Dear Mr. Dow:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boousine is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass build in the 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 I ou may, merelors, mainer ato a Act include requirements for annual registration, listing of general oonlines provided of nactice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease noter 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 If your device is classified (bee acove) Existing major regulations affecting your device can be may be subject to additions, 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 Flease of advised that 1271 5 issuance or our device complies with other requirements of the Act that IDA has made a decommandia as administered by other Federal agencies. You must or any Federal slautes and regulations adminities. but not limited to: registration and listing (21 Comply with an the Act 3 requirements, and 801); medical device reporting (reporting of medical

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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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Poth

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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## 1. Indications for Use

K102018 SEP 2 3 2010

## 510(k) Number (if known): K102018

## Indications:

Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm '. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including frontoorbital areas) such as burr hole voids and other cranial defects.

| Prescription Use | | AND/OR | Over-The-Counter Use |
|----------------------------|---|--------|------------------------|
| (Per 21 CFR 801 Subpart D) | X | | (21 CFR 807 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mondulika Varmani 9/15/10

(Division Sign-Off)

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

510(k) Number_103018