(64 days)
-
- Moderate joint impairment from painful arthritis (rheumatoid, osteo and/or posttraumatic).
-
- Revision of a failed unicompartmental knee implant or other procedure.
-
- Alternative to tibial osteotomy in patients with unicompartmental arthritis.
StelKast Unicondylar Knee System
I'm sorry, but this document does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a medical device (StelKast Unicondylar Knee System), which indicates that the device is substantially equivalent to a legally marketed predicate device.
The clearance letter does not include:
- Acceptance criteria for device performance.
- Any study details for evaluating the device's performance against acceptance criteria (e.g., sample size, data provenance, expert involvement, ground truth methods, MRMC studies, or standalone algorithm performance).
The information provided pertains to regulatory clearance, not performance study outcomes.
{0}------------------------------------------------
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with three flowing lines above it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2003
Mr. Donald A. Stevens President StelKast Company 200 Hidden Valley Road McMurrav, Pennsylvania 15317
Re: K032824
Trade/Device Name: StelKast Unicondylar Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: September 3, 2003 Received: September 10, 2003
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 contrôls 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.
{1}------------------------------------------------
Page 2 - Mr. Donald A. Stevens
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 (301) 594-4659. 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,
Mich N Mullikin
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
{2}------------------------------------------------
K032824 510(K) Number (if known):
StelKast Unicondylar Knee System Device Name:
Indications For Use:
-
- Moderate joint impairment from painful arthritis (rheumatoid, osteo and/or posttraumatic).
-
- Revision of a failed unicompartmental knee implant or other procedure.
-
- Alternative to tibial osteotomy in patients with unicompartmental arthritis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark n Milken
(Division Sig
Division of C al. Restorative
and Neurolog devices
K032824
510(k) Numb
Prescription Use _
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
Page 1 of 1
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.