(85 days)
-
- Fractures of the proximal femur
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- Non-unions of proximal femoral neck fractures.
- Aseptic necrosis of the femoral head: 3.
-
- Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
-
- Salvage of failed total hip arthroplasty.
Not Found
I am sorry, but the provided text from the FDA 510(k) notification for the "Skelkast Bipolar System" (K972961) does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
This document is a letter from the FDA stating that the device has been determined to be substantially equivalent to a legally marketed predicate device and can therefore be marketed. It lists the indications for use but does not detail any performance metrics, study design, or results that you have requested.
Therefore, I cannot provide the information requested in your prompt based on the input text.
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Image /page/0/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 a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1997
Mr. Donald A. Stevens President Skelkast, Inc. 800 Vinal Street, Suite B-210 Pittsburgh, Pennsylvania 15212
K972961 Re: Skelkast Bipolar System Regulatory Class: II Product Codes: KWY and JDI Dated: August 8, 1997 Received: August 11, 1997
Dear Mr. Stevens:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Donald A. Stevens
This letter will allow you to begin marketing your device as described in your 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 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known): K972961
Device Name: StelKast Bipolar System
Indications For Use:
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- Fractures of the proximal femur
-
- Non-unions of proximal femoral neck fractures.
- Aseptic necrosis of the femoral head: 3.
-
- Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
-
- Salvage of failed total hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K97296/
Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.