(52 days)
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.
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.
The provided text is a "Summary of Safety and Effectiveness" for the MAYO® Conservative Hip Prosthesis. It details the device's description, intended use, and comparison to predicate devices. However, the document states: "Non-clinical performance testing demonstrated that the device is equivalent to the predicate."
This statement indicates that the regulatory submission relied on non-clinical performance data to show equivalence to a predicate device, rather than a clinical study with specific acceptance criteria and detailed device performance metrics relevant to an AI/Software as a Medical Device (SaMD).
Therefore, based on the provided text, I cannot extract the information required for your request, as it pertains to AI/SaMD performance studies. There is no mention of:
- Acceptance criteria tables with reported device performance for an AI/SaMD.
- Sample sizes, data provenance, or ground truth for test or training sets for an AI/SaMD.
- Expert involvement (number, qualifications, adjudication methods) for establishing AI/SaMD ground truth.
- MRMC comparative effectiveness studies or standalone AI performance.
The document describes a traditional medical device (hip prosthesis) and its regulatory clearance process, which focuses on demonstrating equivalence to existing devices through manufacturing processes, materials, and non-clinical testing, rather than AI model performance.
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| MAY - 1 2003 | Summary of Safety and Effectiveness |
|---|---|
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
| Contact Person: | Laura D. Williams, RACSr. Associate, Regulatory AffairsTelephone: (574) 372-4523Fax: (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-constrainedporous-coated uncemented prosthesis21 CFR § 888.3358 |
| Predicate Devices: | MAYO Conservative Hip Prosthesis, manufacturedby Zimmer, K943230, cleared January 14, 1997VerSys® Fiber Metal Taper Hip Prosthesis,manufactured by Zimmer, K964769, clearedFebruary 13, 1997Harris/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 HipProsthesis is a modular femoral stem intended toreplace the hip joint in total hip arthroplasty. It isused with a variety of modular femoral heads. Thestem is collarless, wedge-shaped, and is intendedfor use without bone cement. Fixation is achievedby biological ingrowth into the fiber metal pads andby mechanical press fit into the proximal femoralshaft. |
| Intended Use: | The MAYO 12/14 Conservative Hip Prosthesis isindicated for cementless use in skeletally matureindividuals undergoing primary surgery for total hip |
| replacement. Diagnostic indications include severehip pain and disabilities due to rheumatoid arthritis,osteoarthritis, traumatic arthritis, polyarthritis,slipped capital femoral epiphysis, fused hip, fractureof the pelvis, and diastrophic variant. | |
| Comparison to Predicate Device: | The MAYO 12/14 Hip is packaged, manufacturedand sterilized using the same materials andprocesses as the predicates. The MAYO 12/14 Hipwill be available with a 12/14 Morse-type taperneck, and with or without HA/TCP coating. |
| Performance Data: | Non-clinical performance testing demonstrated thatthe device is equivalent to the predicate. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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) |
§ 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.