(29 days)
- Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
- Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.
- For cemented use only.
Not Found
The provided text describes a 510(k) premarket notification for a medical device: "Proven Modular Posterior Stabilized Femoral Component" (part of the "StelKast Proven Cemented, Semi-Constrained Total Knee System"). This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert qualifications.
The 510(k) pathway, particularly for devices like this knee component, primarily relies on demonstrating substantial equivalence to a predicate device already on the market. This typically involves performance testing (e.g., mechanical, wear, fatigue) to show that the new device performs as safely and effectively as the predicate, rather than broad clinical studies with human participants that establish de novo performance criteria or compare AI-assisted human performance.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria, study design, and ground truth as these are not present in the provided FDA letter.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of three human profiles facing to the right. The design is stylized and appears to be made of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 9 2002
Mr. Donald A. Stevens President StelKast Company 200 Hidden Valley Road McMurray, Pennsylvania 15317
Re: K021908
Trade/Device Name: Proven Modular Posterior Stabilized Femoral Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: June 6, 2002 Received: June 10, 2002
Dear Mr. Stevens:
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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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 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,
Neil RP Ogden
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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KO2 1908 510(K) Number (if known):
StelKast Proven Cemented, Semi-Constrained Device Name: Total Knee System K980276
Indications For Use:
-
- Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
-
- Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.
-
- For cemented use only.
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021908
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.