NORIAN DRILLABLE

K073303 · Synthes (Usa) · OIS · Jul 2, 2008 · Orthopedic

Device Facts

• Record ID: K073303
• Device Name: NORIAN DRILLABLE
• Applicant: Synthes (Usa)
• Product Code: OIS · Orthopedic
• Decision Date: Jul 2, 2008
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Norian Drillable Bone Void Filler and Norian Drillable Fast Set PuttyTM 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 Bone Void Filler and Norian Drillable Fast Set Putty™ can be used as an adjunct to conventional rigid hardware fixation by supporting bone fragments during the surgical procedure. Once the material is set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty™ are intended to be placed into bony voids either before or after final fixation.

Device Story

Norian Drillable Bone Void Filler and Fast Set Putty are moldable, biocompatible bone void fillers containing reinforcing fibers. Used in surgical settings by physicians to fill bony voids or defects in extremities and pelvis. Material is mixed (via rotary mixer or manual cup/spatula) to form a viscous paste; injected or placed into defects before or after rigid hardware fixation. Acts as temporary support for bone fragments during surgery; sets at body temperature. Material resorbs over years, replaced by natural bone. Benefits include support for bone fragments during healing; drillable/tappable once cured.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Resorbable calcium salt bone void filler with reinforcing fibers. Supplied as sterile powder and mixing solution. Delivery via injectable paste (rotary mixer) or manual putty (cup/spatula). Sets at body temperature (37°C). Drillable and tappable once cured. Class II device.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in extremities and pelvis not intrinsic to bony stability. Contraindicated for use in the spine, including the pedicle, due to risk of material leakage into the bloodstream.

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 (K011897)
• Norian SRS Fast Set Putty™ (K041842)
• Osteobiologics Polygraft™ Bone Graft Substitute (K030288)
• Wright Medical MIIG II Bone Graft Substitute (K024336)

Submission Summary (Full Text)

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## 1. 510(k) Summary

100 Children

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| Sponsor: | Synthes Biomaterials<br>1230 Wilson Drive<br>West Chester, PA 19380 | JUL - 2 2008 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Company<br>Contact | Jeffrey L. Dow, JD<br>Director, Clinical & Regulatory Affairs<br>Synthes Biomaterials<br>484 356 9720<br>[e-mail] | |
| Device Name: | Norian Drillable™ Bone Void Filler and Norian Drillable™<br>Fast Set 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 (K011897)<br>Norian SRS Fast Set Putty™ (K041842)<br>Osteobiologics Polygraft™ Bone Graft Substitute (K030288)<br>Wright Medical MIIG II Bone Graft Substitute (K024336) | |
| Device<br>Description: | Norian Drillable Bone Void Filler and Norian Drillable Fast Set<br>Putty™ are moldable, biocompatible bone void fillers with<br>added reinforcing fibers. Norian Drillable Bone Void Filler<br>and Norian Drillable Fast Set Putty™ are intended to be placed<br>into bony voids or defects of the. extremities or pelvis either<br>before or after final fixation. The material can be drilled and<br>tapped, and screws can be placed through it at any time during<br>or after the setting process. When fully cured, the composition<br>formed closely approximates the mineral phase of bone. | |
| | The product is available in two delivery forms. Norian<br>Drillable Bone Void Filler is an injectable paste that is mixed<br>with an automatic mixer, and Norian Drillable Fast Set Putty™<br>is manually mixed with a cup and spatula. | |
| | Norian Drillable Bone Void Filler is provided in a sterile pouch<br>(the "Reactants Pack"). The Reactants Pack is constructed of a<br>clear-film outer pouch and a foil laminate inner pouch with an<br>attached delivery syringe. The Reactants Pack 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 | |

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mixing solution is contained in the Solution Syringe, which is packaged separately.

The Reactants Pack is designed to be placed in a reusable mixer (the "Rotary Mixer") 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 Drillable Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes. Norian Drillable Bone Void Filler is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Drillable 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 Drillable Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Drillable Fast Set Putty™ is slowly resorbed over a period of years and replaced with bone during the healing process.

#### Intended Use:

Norian Drillable Bone Void Filler and Norian Drillable Fast Set PuttyTM 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 Bone Void Filler and Norian Drillable Fast Set Putty™ can be used as an adjunct to conventional rigid hardware fixation by supporting bone fragments during the surgical procedure. Once the material is set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty™ are intended to be placed into bony voids either before or after final fixation.

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### Substantial Equivalence:

Documentation is provided that demonstrates that Norian Drillable is substantially equivalent to other legally marketed devices.

^&#x27; 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 & Cosmetic Act, as amended, and as applied under 21 CFR Part 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalence under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein, shall be construed as an admission against interest under the U.S. patent laws or their application by the courts.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL - 2 2008

Synthes (USA) c/o Mr. Jeffrey L. Dow, JD Director, Clinical and Regulatory Affairs, Biomaterials 1302 Wrights Lane East West Chester, PA 19380

Re: K073303

Device Name: Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty Regulation Number: 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: OIS, MQV Dated: June 3, 2008 Received: June 4, 2008

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Contraindications section of the device's labeling.

The safety and effectiveness of this device for use in the spine has not been established.

Use of this device is contraindicated in the spine, including use in the pedicle, as this could be associated with leakage of the device material into the bloodstream, which could cause serious adverse events, including death.

Furthermore, the indications for use and contraindications for use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of at least 10 point font, and in bold print.

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Page 2 - Mr. Jeffrey L. Dow, JD

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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); good manufacturing practice reguirements 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### 510(k) Number (if known): K073303

Device Name: Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty

Indications For Use:

Norian Drillable Bone Void Filler 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 Bone Void Filler and Norian Drillable Fast Set Putty™ can be used as an adjunct to conventional rigid hardware fixation by supporting bone fragments during the surgical procedure. Once the material is set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty™ are intended to be placed into bony voids either before or after final fixation.

Prescription Use X (Part 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 DRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

§10(k) Number.