(181 days)
Fast Set Putty is indicated for repairing or filling craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². Fast Set Putty is also indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including the fronto-orbital, malar and mental areas.
Fast Set Putty is a putty-like calcium phosphate bone cement characterized by a rapid in situ setting time. The Fast Set Putty components are supplied sterile in two separate containers. The putty is intraoperatively prepared by manually mixing the components within a cup using a spatula. Once complete, the putty can be shaped and contoured by hand.
This document is a 510(k) summary for the Synthes (USA) Fast Set Putty, a calcium phosphate bone cement. It addresses the substantial equivalence to a predicate device and provides details on its intended use and material. However, it does not contain information regarding an acceptance criteria table, a study proving device meets acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information from the provided text. The document is primarily a regulatory submission for market clearance, focusing on safety and efficacy based on substantial equivalence, rather than a detailed performance study report.
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KO12589
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FEB 0 7 2002
510(k) Summary 3.0
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Thomas M. Maguire |
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| DEVICE NAME: | Fast Set Putty |
| CLASSIFICATION: | Class II, 21 CFR 882.5300: Methyl Methacrylate for Cranioplasty. |
| PREDICATE DEVICE: | Documentation was provided which demonstrated Fast Set Putty to besubstantially equivalent to other previously cleared devices. |
| DEVICE DESCRIPTION: | Fast Set Putty is a putty-like calcium phosphate bone cement characterizedby a rapid in situ setting time. The Fast Set Putty components are suppliedsterile in two separate containers. The putty is intraoperatively prepared bymanually mixing the components within a cup using a spatula. Oncecomplete, the putty can be shaped and contoured by hand. |
| INTENDED USE: | Fast Set Putty is indicated for repairing or filling craniofacial defects andcraniotomy cuts with a surface area no larger than 25cm². Fast Set Putty isalso indicated for the restoration or augmentation of bony contours of thecraniofacial skeleton, including the fronto-orbital, malar and mental areas. |
| MATERIAL: | Calcium Phosphate |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2002
Mr. Thomas M. Maguire Project Leader, Regulatory Affairs Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K012589
Trade/Device Name: CRS Fast Set Putty Regulation Number: 21 CFR 882.5300 Regulation Name: methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: GXP Dated: December 6, 2001 Received: December 10, 2001
Dear Mr. Maguire:
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 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.
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Page 2 - Mr. Thomas M. Maguire
This letter will allow you to begin marketing your device as described in your Section 510(k) I me letter will and a your hinding 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
b. Mark N. Milliman
Celia M. Witten, Ph.D., M.D. 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 2.0
Page _ 1 ______ of __ 1
KO12589 510(k) Number (if known):
Synthes (USA) Fast Set Putty Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications/Contraindications:
Fast Set Putty is indicated for repairing or filling craniofacial defects and craniotomy cuts with a surface r ast Set I uty is indicated for ropaning of mining stilling with restoration or augmentation of bony area no larger man 290m : I as been including the fronto-orbital, malar and mental areas.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Division Sign-Off
Lision of Gener Restorative
and Neurological Devices
510(k) Number K012589
Confidential
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
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.(b)
Classification. Class II (performance standards).