(32 days)
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 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.
Based on the provided text, the document is a 510(k) Summary for a medical device (Norian SRS Fast Set Putty) and the FDA's clearance letter. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It does not contain information about acceptance criteria for device performance studies, nor does it describe any specific study that proves the device meets such criteria.
The document primarily focuses on:
- Device classification and description.
- Indications for Use and Contraindications.
- Identification of a predicate device (Norian SRS Fast Set Putty, K041842).
- A statement of substantial equivalence to the predicate in terms of material composition, physical properties, and performance characteristics.
Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as this information is not present in the provided text.
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K 060406
3. 510(k) Summary
MAR 2 0 2006
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380 |
|---|---|
| Contact: | Angela J. SilvestriSynthes (USA)1230 Wilson DriveWest Chester, PA 19380(484) 356-9728 |
| 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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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- 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_
4
N/A