(52 days)
Not Found
No
The document describes a mechanical hip prosthesis and does not mention any AI or ML components or functionalities.
Yes
The device is a total hip prosthesis intended to replace a damaged hip joint, which directly treats and alleviates medical conditions like severe hip pain and disabilities, fitting the definition of a therapeutic device.
No
The device is a prosthesis indicated for total hip replacement, and while it mentions "Diagnostic indications" for the conditions it addresses, the device itself is not used to diagnose those conditions. Its purpose is to replace the hip joint.
No
The device description clearly states it is a modular femoral stem intended to replace the hip joint, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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 for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a hip prosthesis, which is an implantable device used to replace a damaged hip joint. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use is for total hip replacement surgery to address severe hip pain and disabilities caused by various conditions. This is a therapeutic intervention, not a diagnostic process.
The diagnostic indications mentioned in the "Intended Use" section refer to the conditions that lead to the need for the hip replacement, not that the device itself is performing a diagnostic test.
N/A
Intended Use / Indications for Use
The MAYO 12/14 Conservative Hip Prosthesis is indicated for cementless use in skeletally mature individuals undergoing primary surgery for total hip replacement. Diagnostic indications include severe hip pain and disabilities due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Product codes
LPH
Device Description
Like the predicate MAYO Hip, the MAYO 12/14 Hip Prosthesis is a modular femoral stem intended to replace the hip joint in total hip arthroplasty. It is used with a variety of modular femoral heads. The stem is collarless, wedge-shaped, and is intended for use without bone cement. Fixation is achieved by biological ingrowth into the fiber metal pads and by mechanical press fit into the proximal femoral shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
Indicated Patient Age Range
skeletally mature individuals
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
Non-clinical performance testing demonstrated that the device is equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the word "zimmer" in a stylized font. The first letter, "Z", is capitalized and enclosed in a circle. The rest of the word is in lowercase and has a slightly different font. There is a horizontal line under the word.
| MAY - 1 2003 | Summary of Safety and Effectiveness |
|---|---|
| Submitter: | Zimmer, Inc. |
| P.O. Box 708 | |
| Warsaw, IN 46581-0708 | |
| Contact Person: | Laura D. Williams, RAC |
| Sr. Associate, Regulatory Affairs | |
| Telephone: (574) 372-4523 | |
| Fax: (574) 372-4605 | |
| Date: | March 7, 2003 |
| Trade Name: | MAYO®* Conservative Hip Prosthesis |
| Common Name: | Total hip prosthesis |
| Classification Name and Reference: | Hip joint metal/polymer/metal semi-constrained |
| porous-coated uncemented prosthesis | |
| 21 CFR § 888.3358 | |
| Predicate Devices: | MAYO Conservative Hip Prosthesis, manufactured |
| by Zimmer, K943230, cleared January 14, 1997 |
VerSys® Fiber Metal Taper Hip Prosthesis,
manufactured by Zimmer, K964769, cleared
February 13, 1997
Harris/Galante Hip System with Calcicoat®
Ceramic Coating, manufactured by Zimmer,
K980711, cleared November 12. 1998 |
| Device Description: | Like the predicate MAYO Hip, the MAYO 12/14 Hip
Prosthesis is a modular femoral stem intended to
replace the hip joint in total hip arthroplasty. It is
used with a variety of modular femoral heads. The
stem is collarless, wedge-shaped, and is intended
for use without bone cement. Fixation is achieved
by biological ingrowth into the fiber metal pads and
by mechanical press fit into the proximal femoral
shaft. |
| Intended Use: | The MAYO 12/14 Conservative Hip Prosthesis is
indicated for cementless use in skeletally mature
individuals undergoing primary surgery for total hip |
| | replacement. Diagnostic indications include severe
hip pain and disabilities due to rheumatoid arthritis,
osteoarthritis, traumatic arthritis, polyarthritis,
slipped capital femoral epiphysis, fused hip, fracture
of the pelvis, and diastrophic variant. |
| Comparison to Predicate Device: | The MAYO 12/14 Hip is packaged, manufactured
and sterilized using the same materials and
processes as the predicates. The MAYO 12/14 Hip
will be available with a 12/14 Morse-type taper
neck, and with or without HA/TCP coating. |
| Performance Data: | Non-clinical performance testing demonstrated that
the device is equivalent to the predicate. |
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Image /page/1/Picture/0 description: The image contains the word "zimmer" in a stylized font. The "z" is a large, bold letter inside of a circle. The rest of the word is in a smaller, sans-serif font.
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.
Public Health Service
MAY = 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura D. Williams, RAC Sr. Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Re: K030733
Trade/Device Name: MAYO® Conservative Hip Prosthesis Regulation Number: 888.3358 Regulation Name: Hip joint/metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: March 7, 2003 Received: March 10, 2003
Dear Ms. Williams:
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
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Page 2 - Laura D. Williams
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. 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.
Mark A. Millerson
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of 1
510(k) Number (if known):
长02,0733
Device Name:
MAYO® Conservative Hip Prosthesis
Indications for Use:
The MAYO Conservative Hip Prosthesis is indicated for cementless use in skeletally mature individuals undergoing primary surgery for total hip replacement. Diagnostic indications include severe hip pain and disabilities due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
(Please do not write below this line - Continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | |
|---|---|---|
| Division of General, Restorative and Neurological Devices | ||
| 510(k) Number | K030733 | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |