NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY

K102722 · Synthes USA Products, LLC · MQV · Jan 27, 2011 · Orthopedic

Device Facts

• Record ID: K102722
• Device Name: NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
• Applicant: Synthes USA Products, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Jan 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

Intended Use

Norian Drillable Inject and Norian Drillable Fast Set Putty are intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids either before or after final fixation.

Device Story

Moldable, biocompatible bone void fillers containing reinforcing fibers; intended for filling non-structural bony voids/defects in extremities and pelvis. Two forms: Injectable paste (mixed via automatic rotary mixer) and manual putty (mixed via cup/spatula). Material sets at body temperature; drillable and tappable; allows screw placement during or after setting. Acts as temporary support medium during surgery; slowly resorbed and replaced by bone over years. Used by surgeons in clinical settings as adjunct to rigid hardware fixation.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing.

Technological Characteristics

Resorbable calcium salt bone void filler; contains reinforcing fibers. Supplied as sterile powder and mixing solution. Injectable form uses rotary mixer; putty form uses manual cup/spatula. Sets at body temperature (37°C).

Indications for Use

Indicated for patients with surgically created or traumatic bony voids or defects in the extremities and pelvis that are not intrinsic to bony structure stability. Not for use as structural support during the healing process.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• Norian SRS Bone Void Filler and Norian SRS Fast Set Putty (K073303)

Submission Summary (Full Text)

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K102722

JAN 2 7 2011

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| 2. 510(k) Summary | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes Biomaterials<br>1230 Wilson Drive<br>West Chester, PA 19380 |
| Company Contact | Jeffrey L. Dow, JD<br>Director, Clinical & Regulatory Affairs<br>Synthes Biomaterials<br>484 356 9720<br>[e-mail] |
| Device Name: | Norian Drillable™ Inject and Norian Drillable™ Fast Set<br>Putty™ |
| Classification: | Class II, 21 CFR §888.3045<br>Filler, bone void, calcium compounds. |
| Product Codes | MQV, OIS |
| Predicate Devices | Norian SRS Bone Void Filler and Norian SRS Fast Set Putty<br>(K073303) |
| Device Description: | Norian Drillable Inject and Norian Drillable Fast Set Putty are<br>moldable, biocompatible bone void fillers with added<br>reinforcing fibers. Norian Drillable Inject and Norian Drillable<br>Fast Set Putty are intended to be placed into bony voids or<br>defects of the extremities or pelvis either before or after final<br>fixation. The material can be drilled and tapped, and screws can<br>be placed through it at any time during or after the setting<br>process. When fully cured. the composition formed closely<br>approximates the mineral phase of bone. |
| | The product is available in two delivery forms. Norian<br>Drillable Inject is an injectable paste that is mixed with an<br>automatic mixer, and Norian Drillable Fast Set Putty is<br>manually mixed with a cup and spatula. |
| | Norian Drillable Inject is provided in a sterile pouch (the<br>"Rotary Pouch"). The Rotary Pouch is constructed of a clear-<br>film outer pouch and a foil laminate inner pouch with an<br>attached delivery syringe. The Rotary Pouch contains sterile<br>powder with fibers and is designed with an injection port for the<br>purpose of adding the mixing solution to the pouch. The<br>mixing solution is contained in the Solution Syringe, which is |

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| | The Rotary Pouch is designed to be placed in a reusable mixer<br>(the “Rotary Mixer”) where the two components are mixed<br>together to form a smooth, viscous paste. The paste remains<br>injectable for approximately 5 minutes at 18°-23°C / 64°-73°F.<br>At body temperature (37°C / 98.6°F), Norian Drillable Inject<br>begins to harden after 2 minutes and sets in approximately 10<br>minutes. Norian Drillable Inject is slowly resorbed over a<br>period of years and replaced with bone during the healing<br>process. |
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| | Norian Drillable Fast Set Putty is supplied in two containers.<br>The mixing cup holds sterile powder with fibers and the<br>Solution Syringe holds sterile solution. When the powder and<br>solution are mixed together with the provided cup and spatula,<br>the resultant putty material can be manipulated for two minutes<br>at 18°-23°C / 64°-73°F. |
| | At body temperature (37°C / 98.6°F), Norian Drillable Fast Set<br>Putty begins to harden after 2 minutes and sets in approximately<br>3 to 6 minutes. Norian Drillable Fast Set Putty is slowly<br>resorbed over a period of years and replaced with bone during<br>the healing process. |
| Intended Use: | Norian Drillable Inject and Norian Drillable Fast Set Putty are<br>intended for bony voids or defects of the extremities and pelvis<br>that are not intrinsic to the stability of the bony structure. These<br>defects may be surgically created osseous defects or osseous<br>defects created from traumatic injury to the bone. The product<br>provides a bone void filler that resorbs and is replaced with<br>bone during the healing process. Norian Drillable Inject and<br>Norian Drillable Fast Set Putty can be used as an adjunct to<br>conventional rigid hardware fixation by supporting the bone<br>fragments during the surgical procedure. Once the material has<br>set, it acts as a temporary support medium and is not intended to<br>provide structural support during the healing process. Norian<br>Drillable Inject and Norian Drillable Fast Set Putty are intended<br>to be placed into bony voids either before or after final fixation. |
| Substantial<br>Equivalence: | Documentation is provided that demonstrates that Norian<br>Drillable is substantially equivalent to other legally marketed<br>devices. |

⁴ The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.

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

Synthes (USA) c/o Mr. Jeffrey L. Dow, JD Director, Clinical and Regulatory Affairs, Biomaterials 1230 Wilson Drive West Chester, PA 19380

JAN 2 7 2011

Re: K102722

Device Name: Norian Drillable Inject and Norian Drillable Fast Set Putty Regulation Number: 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV, OIS Dated: January 14, 2011 Received: January 18, 2011

Dear Mr. Dow:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 -- Mr. Jeffrey L. Dow, JD

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 1000-10501-0

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/CDRHOffices/uccn11158001/jphf 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 (11 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 vours

R. N. Mallekson

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized letter inside of a circle. A small circle is located to the right of the word, likely indicating a registered trademark. The text and logo are centered on a white background.

K102722

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## 1. Indications for Use Statement

Norian Drillable Inject and Norian Drillable Fast Set Putty are intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids either before or after final fixation.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Lounne M. Bugar

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102722