(88 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a ceramic femoral head, with no mention of AI or ML.
Yes
The device is a modular component for total hip arthroplasty, intended to alleviate severe hip pain and disability caused by various conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a component for hip arthroplasty, used to replace parts of the hip joint. Its purpose is therapeutic (implantable), not diagnostic.
No
The device is a physical implant (femoral head) made of Alumina Ceramic, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating hip conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical component (femoral head) made of ceramic, designed to be implanted in the body. This is consistent with a medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical testing and equivalence to existing implants, which are relevant for a surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Alumina Ceramic Femoral Heads are modular components designed for use in total hip arthroplasty and indicated for the following:
Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
Product codes
LZO
Device Description
The Alumina Ceramic Femoral Heads are single-use devices manufactured from Al2O3. Both 28 and 32 mm diameter heads are available in three neck lengths each. The 12/14 bore of the ceramic ball mates with Zimmer titanium and cobalt-chromium alloy femoral stems having a corresponding 12/14 neck taper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Mechanical testing was performed per the FDA Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems. Test results indicate that the Alumina Ceramic Femoral Heads are equivalent to devices currently on the market and capable of withstanding in vivo loading.
Key Metrics
Not Found
Predicate Device(s)
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/0 description: The image shows the logo for Zimmer. The logo consists of a large, stylized "Z" inside of a circle on the left, and the word "zimmer" in bold, sans-serif font on the right. The logo is black and white.
JUN - 3 2003
Summary of Safety and Effectiveness
030724
page 1 of 2
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Cain
Manager, Regulatory Affairs
Telephone: (574) 372-4219
Fax: (574) 372-4605 |
| Date: | March 3, 2003 |
| Trade Name: | Alumina Ceramic Femoral Heads, 28 and 32 mm |
| Common Name: | Ceramic Femoral Head Prosthesis |
| Classification Name
and Reference: | Hip joint metal/ceramic/polymer semiconstrained
cemented or nonporous uncemented prosthesis
21 CFR § 888.3353 |
| Predicate Devices: | Zimmer Ceramic Femoral Heads, K905739 and
K914676, cleared March 7, 1991, and January 13,
1992, respectively. |
| Device Description: | The Alumina Ceramic Femoral Heads are single-
use devices manufactured from Al 2 O 3 . Both 28 and
32 mm diameter heads are available in three neck
lengths each. The 12/14 bore of the ceramic ball
mates with Zimmer titanium and cobalt-chromium
alloy femoral stems having a corresponding 12/14
neck taper. |
| Indications for Use: | The Alumina Ceramic Femoral Heads are modular
components designed for use in total hip
arthroplasty and indicated for the following:
Patients suffering from severe hip pain and
disability due to rheumatoid arthritis, osteoarthritis,
traumatic arthritis, polyarthritis, collagen disorders,
avascular necrosis of the femoral head, and
nonunion of previous fractures of the femur;
patients with congenital hip dysplasia, protrusio |
1
Image /page/1/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside a circle, followed by the word "zimmer" in a bold, sans-serif font. The logo is black and white and appears to be a vector graphic.
Image /page/1/Picture/2 description: The image shows handwritten text that appears to be a combination of an identifier and page information. The text "KO 30724" is written on the top line, likely serving as a document or project identifier. Below this, the text "page 2 of 2" indicates that this is the second page of a two-page document.
Comparison to Predicate Device:
Performance Data:
acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
The Alumina Ceramic Femoral Heads are substantially equivalent to the femoral heads listed above as predicate devices. Both designs are intended to function as a modular femoral head component in hip arthroplasty and are manufactured from AbO3 ceramic.
Mechanical testing was performed per the FDA Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems. Test results indicate that the Alumina Ceramic Femoral Heads are equivalent to devices currently on the market and capable of withstanding in vivo loading.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wings. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2003
Ms. Karen Cain Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K030724
Trade/Device Name: Alumina Ceramic Femoral Heads, 28 and 32 mm Regulation Numbers: 21 CFR 888.3353 Regulation Names: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO Dated: March 3, 2003 Received: March 7, 2003
Dear Ms. Cain:
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. Iisting 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
3
Page 2- Ms. Karen Cain
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. 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 vours.
R. Mark N. 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
4
Indications for Use
KO30724
510(k) Number (if known):
Device Name:
Alumina Ceramic Femoral Heads, 28 and 32 mm
Indications for Use:
The Alumina Ceramic Femoral Heads are modular components designed for use in total hip arthroplasty and indicated for the following:
Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
| 510(k) Number | K030724 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
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