(90 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a ceramic femoral head for hip replacement, with no mention of AI or ML.
Yes
The device is a component of total hip arthroplasty, replacing damaged parts of the hip joint to alleviate severe pain and disability, which aligns with the definition of a therapeutic device.
No
The device is a component of a total hip arthroplasty, designed to be implanted to treat conditions like arthritis and fractures, not to diagnose them.
No
The device description clearly indicates it is a physical implant made of ceramic material, intended for surgical implantation. It is a hardware device, 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 designed to be implanted into the human hip as a component in total hip arthroplasty. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details the material and design of a physical implant intended for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The 22 mm Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is 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 22 mm Zirconia Ceramic Femoral Head is made from yttria stabilized zirconium oxide (ZrO3) ceramic and provides an alternative to cobalt-chrome alloy femoral heads. The Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Ceramic materials have been successfully used in orthopaedic applications for approximately 20 years. These materials exhibit excellent resistance to corrosion and wear and are highly biocompatible. The yttria stabilized zirconium oxide from which the Zirconia Ceramic Femoral Head is made has a limited clinical history. Although mechanical testing demonstrates that when used with polyethylene acetabular cups, the zirconia ceramic femoral head produces a relatively low amount of particulates, the total amount of particulate produced remains undetermined. Because of limited clinical and preclinical experience, the long-term biological effects of these particulates are unknown. Clinical investigation of the zirconium oxide ceramic prosthesis is ongoing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K944601, K955877, K901480, K901594
Reference Device(s)
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 Biomet. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written in a bold, sans-serif font below it. The letter "Z" is black, and the circle is a thin line. The word "zimmer" is also black.
PO. Box 708 Warsaw, IN 46581-0708 219 267-6131
OCT 1 5 1997
Summary of Safety and Effectiveness 22 mm Zirconia Ceramic Femoral Head, 12/14 Taper
K97 2690
Submitted By: .
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 219-267-6131
Contact Person: .
Karen Cain, Specialist, Global Regulatory Affairs Telephone: 219-372-4219 Fax: 219-372-4605
- Date: .
July 9, 1997
Trade Name: .
Zirconia Ceramic Femoral Head
Common Name: .
Femoral head for total hip joint prosthesis
. Classification Name:
Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, 21 CFR 888.3353
Predicate Devices: .
- Zimmer® Zirconia Ceramic Femoral Head, K944601 and K955877, cleared . January 12, 1995, and October 8, 1996, respectively.
- Astel Cobalt-Chrome Femoral Heads, manufactured by Zimmer, K901480 and . K901594, cleared June 12, 1990, and August 3, 1990, respectively.
Image /page/0/Picture/20 description: The image shows the logo of "A Bristol-Myers Squibb Company". The logo consists of a geometric symbol on the left and the company name on the right. The geometric symbol is a complex design with multiple triangles and lines, while the company name is written in a serif font.
1
Summary of Safety and Effectiveness 22 mm Zirconia Ceramic Femoral Head, 12/14 Taper (Continued)
- Zimmer® Cobalt-Chrome Femoral Heads, described in the premarket notification for the Beta System, K953337, cleared January 22, 1996.
- Zirconia Ceramic Femoral Head, 12/14 Taper, K971752, currently being . reviewed by FDA.
Device Description: ●
The 22 mm Zirconia Ceramic Femoral Head is made from yttria stabilized zirconium oxide (ZrO3) ceramic and provides an alternative to cobalt-chrome alloy femoral heads. The Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component.
Intended Use: .
The 22 mm Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is 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.
Comparison to Predicate Devices: .
The 22 mm Zirconia Ceramic Femoral Head is substantially equivalent to the femoral heads listed above as predicate devices. Each is designed to function as the modular femoral head component of a total hip prosthesis, is impacted onto the proximal taper of a femoral stem at the time of surgery, and articulates upon the UHMWPE-bearing surface of an acetabular component.
The 22 mm Zirconia Ceramic Femoral Head, 12/14 taper, the previously cleared Zimmer Zirconia Ceramic Femoral Head, and K971752 (currently being reviewed by FDA) are made from zirconium oxide ceramic. The size range for the Zirconia Ceramic Femoral Head (12/14 taper) includes 22, 26, 28, and 32 mm diameters. The
2
Summary of Safety and Effectiveness 22 mm Zirconia Ceramic Femoral Head, 12/14 Taper (Continued)
Zimmer Zirconia Ceramic Femoral Head is provided in 22, 26, and 28 mm diameters and supports a different taper for impaction upon the femoral stem component.
Clinical and Nonclinical Data .
Ceramic materials have been successfully used in orthopaedic applications for approximately 20 years. These materials exhibit excellent resistance to corrosion and wear and are highly biocompatible. The yttria stabilized zirconium oxide from which the Zirconia Ceramic Femoral Head is made has a limited clinical history. Although mechanical testing demonstrates that when used with polyethylene acetabular cups, the zirconia ceramic femoral head produces a relatively low amount of particulates, the total amount of particulate produced remains undetermined. Because of limited clinical and preclinical experience, the long-term biological effects of these particulates are unknown. Clinical investigation of the zirconium oxide ceramic prosthesis is ongoing.
RA07701K.510
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest the wings and body. The bird is oriented towards the upper right of the image. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Cain Requlatory Affairs Specialist Global Requlatory Affairs Zimmer Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
OCT 1 5 1997
K972690 Re: Zirconia Ceramic Femoral Head - 22 mm Regulatory Class: II Product Code: LZO July 9, 1997 Dated: Received: July 17, 1997
Dear Ms. Cain:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the Zimmer Biomechanics Zirconia Ceramic Femoral Head is to only be used with the Zimmer Biomechanics 12/14 taper made from Tivanium Ti-6-Al-4V Alloy This information must be identified in or cobal chrome alloy. the package insert.
The general controls provisions of the Act include requirements for annual reqistration, 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 (Premarket Approval), 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 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices:
4
Page 2 - Ms. Karen Cain
through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic enaduct Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Exhibit I
Page _ 1 __ of __ 1 __ 1 __ 1 __ 1 __ 1 __ 1 __ 1 __ 1 __ 1 __ 1 __ 1 __
510(k) Number (if known): 15922490
Device Name: 22 mm Zirconia Ceramic Femoral Head, 12/14 Taper
Indications for Use:
The 22 mm Zirconia Ceramic Femoral Head, 12/14 Taper is designed to be implanted into the human hip as a component in total hip arthroplasty and is 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 (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use |
(Optional Format 1-2-96)
| RA02650K.FM | |
|---|---|
| for (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K97 2690 |
39