NORIAN SRS FAST SET PUTTY

K060406 · Synthes (Usa) · MQV · Mar 20, 2006 · Orthopedic

Device Facts

• Record ID: K060406
• Device Name: NORIAN SRS FAST SET PUTTY
• Applicant: Synthes (Usa)
• Product Code: MQV · Orthopedic
• Decision Date: Mar 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Norian SRS Fast Set Putty is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Fast Set Putty is intended to be placed into bony voids or gaps of the skeletal system (the extremities and pelvis). 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 SRS 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 SRS Fast Set Putty is a self-setting calcium phosphate bone void filler. Supplied as two sterile components, the material is manually mixed in a cup with a spatula to achieve a uniform consistency. Once mixed, the putty is shaped and contoured by hand by a surgeon to fill osseous defects in the extremities or pelvis. The material is resorbed over time and replaced by natural bone during the healing process. Intended for single use only. The device provides a scaffold for bone regeneration in non-load-bearing applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-setting calcium phosphate cement. Provided sterile in two-part kit with mixing cup and spatula. Resorbable material. Manual mixing process.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities and pelvis) not intrinsic to bony stability. Applicable to surgically created or traumatic osseous defects. Contraindicated for use in the spine or in the presence of active/suspected infection.

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 Fast Set Putty (K041842)

Submission Summary (Full Text)

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K 060406

## 3. 510(k) Summary

MAR 2 0 2006

| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
|--------------|-------------------------------------------------------------------------------------------------------|
| Contact: | Angela J. Silvestri<br>Synthes (USA)<br>1230 Wilson Drive<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Norian SRS Fast Set Putty |

Device Classification: 87 MQV - Class II - Filler, Bone Void, Calcium Compound

Device Description: Norian SRS Fast Set Putty is a self-setting calcium phosphate cement. SRS Fast Set Putty components are supplied sterile in two separate containers. It is prepared for use by manually mixing two components within a cup using a spatula. The mixing cup and spatula are included in the device packaging. Once combined into a uniform consistency, the product can be shaped and contoured by hand. Norian SRS Fast Set Putty is gradually resorbed over time. This material is provided sterile and is for single use only.

Indications for use: Norian SRS Fast Set Putty is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Fast Set Putty is intended to be placed into bony voids or gaps of the skeletal system (the extremities and pelvis). 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 SRS Fast Set Putty is not intended for use in the spine and should not be used in the presence of active or suspected infection.

Predicate Device Norian SRS Fast Set Putty, K041842

Substantial Equivalence This device is equivalent to the predicate in terms of material Determination composition, physical properties, and performance characteristics.

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MAR 2 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060406

Trade/Device Name: Norian SRS Fast Set Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 15, 2006 Received: February 16, 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

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Page 2 – Ms. Angela J. Silvestri

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. 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/dsma/dsmamain.html

Sincerely yours,

Herbert Lehman

Mark N. Melkerson Acting 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

KO60406 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ________ Norian SRS Fast Set Putty

Indications For Use:

Norian SRS Fast Set Putty is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Fast Set Putty is intended to be placed into bony voids or gaps of the skeletal system (the extremittes and pelvis). 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.

Contraindications:

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

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

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 Deyice Evaluation (ODE)

Usted Lewis

Division of General, Restorative, and Neurological Devices

510(k) Number_

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