(29 days)
Not Found
No
The provided 510(k) summary focuses on the intended use and indications for a total knee replacement device. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description is consistent with a traditional orthopedic implant.
Yes.
The device is indicated for total knee replacement, which is a medical procedure aimed at treating and improving a patient's health condition (osteoarthritis, osteonecrosis, rheumatoid arthritis, post-traumatic degenerative problems). This falls under the definition of a therapeutic device.
No
The intended use describes the treatment of knee conditions through total knee replacement and revision, which are therapeutic interventions, not diagnostic processes.
No
The provided 510(k) summary describes a total knee replacement device, which is a physical implant, not a software-only medical device. The lack of a device description and mentions of software-related terms further supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure (total knee replacement and revision) for treating conditions affecting the knee joint. This is a therapeutic intervention performed directly on the patient's body.
- Anatomical Site: The anatomical site is the knee joint, which is part of the human body, not a sample taken from the body for testing.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or other materials typically associated with in vitro testing
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a prosthetic implant used in surgery.
N/A
Intended Use / 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.
Product codes
JWH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged on a single line, with "Public" and "Health" being slightly larger than "Service". The text is black against a white background.
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle head in profile, with three parallel lines extending from the back of the head to represent feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
MAR 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald A. Stevens President StelKast Company 200 Hidden Valley Road McMurray, Pennsylvania 15317
Re: K030577
Trade/Device Name: Proven Modular Tibial Tray Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 20, 2003
Dear Mr. Stevens:
Received: February 24, 2003
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
1
Page 2 - Mr. Donald A. Stevens
forth in the quality systems (OS) 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 (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,
Sincerely yours,
Mark McMherm
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
510(K) Number (if known):
Device Name: StelKast Proven Cemented, Semi-Constrained Total Knee System K980276 & K000113
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General Restorative
and Neurological Devices
| 510(k) Number | K030577 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR |
|---|---|
| (Per 21 CFR 801.109) | Over-The-Counter Use |
(Optional Format 1-2-96)