(84 days)
Not Found
Not Found
No
The summary describes a physical medical device (a femoral head) and contains no mention of software, algorithms, AI, or ML.
Yes
The device is used for reconstruction of the articulating surface of the femoral head to relieve pain and disability, which aligns with the definition of a therapeutic device.
No
Explanation: This device is described as a "Modular Ceramic Femoral Head" used for "reconstruction of the articulating surface of the femoral head portion of the hip." This indicates it is a therapeutic or reconstructive device, not one designed to diagnose a condition.
No
The device description clearly identifies the device as a "32mm Modular Ceramic Femoral Head," which is a physical implantable component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the reconstruction of the articulating surface of the femoral head portion of the hip. This is a surgical implant used in vivo (within the body) to replace a damaged anatomical structure.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
- Device Description: The description confirms it's a "Modular Ceramic Femoral Head," which is a component of a hip replacement prosthesis.
Therefore, the 32mm Modular Ceramic Femoral Head is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 32mm Modular Ceramic Femoral Head is a single use device used for reconstruction of the articulating surface of the femoral head portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head.
Product codes
LZO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head portion of the hip
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2004
Donald A. Stevens President StelKast Company 200 Hidden Valley Road Mc Murray, Pennsylvania 15317
Re: K033944
Trade/Device Name: StelKast 32mm Modular Ceramic Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: December 18, 2003 Received: December 19, 2004
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 adviscd 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 - 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,
L. Merle A. Wilkerson
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): | K033944 |
|---|---|
| --------------------------- | --------- |
StelKast 32mm Modular Ceramic Femoral Head Device Name:
Indications For Use:
The 32mm Modular Ceramic Femoral Head is a single use device used for reconstruction of the articulating surface of the femoral head portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mad A Milkus
for (Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| (k) Number | K033944 |
|---|---|
| ------------ | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
|---|---|---|---|
| ------------------------------------------ | ------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)