(208 days)
No
The document describes a mechanical hip prosthesis and explicitly states that mentions of AI, DNN, or ML were not found.
Yes
The device, a hip prosthesis, is used to replace a hip joint in total hip replacement surgery for individuals with severe hip pain and disabilities due to various conditions like arthritis or fractures, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is a prosthesis indicated for total hip replacement, specifically for severe hip pain and disabilities caused by various conditions. While it replaces a joint due to diagnosed conditions, it does not diagnose those conditions itself. The "Diagnostic indications" section refers to the conditions for which the prosthesis is used, not a diagnostic function of the device.
No
The device description clearly states it is a modular femoral stem, 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 about a person's health.
- Device Description: The MAYO Conservative Hip Prosthesis is a surgical implant designed to replace a damaged hip joint. It is physically inserted into the body during surgery.
- Intended Use: The intended use is for total hip replacement surgery to address severe hip pain and disabilities. This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / 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.
Product codes
LPH
Device Description
Like its predicate, the modified MAYO Conservative Hip Prosthesis is a modular femoral stem intended to replace the hip joint in total hip arthroplasty. It is identical to its predicate in that it features a 12/14 Morse-type taper and uses the same variety of modular femoral heads. It differs only in overall size where the design is intended to address smaller patient anatomies. As with the predicate, the proposed stem is collarless, wedge-shaped, and is designed for use without bone cement. Fixation is achieved by mechanical press fit into the proximal femoral shaft and by biological ingrowth into the fiber metal pads. As with the predicate, the proposed device is available with and without Calcicoat® Ceramic Coating (HA/TCP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions: Engineering evaluations demonstrated that the device is equivalent to the predicate.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
DEC 2 0 2006
:
KO61461 Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Jenks
Specialist, Regulatory Affairs
Telephone: (574) 371-8354
Fax: (574) 372-4605 |
| Date: | May 24, 2006 |
| Trade Name: | MAYO ® Conservative Hip Prosthesis |
| Common Name: | Total Hip Prosthesis |
| Classification Name
and Reference: | Prosthesis, Hip, Semi-constrained Metal/Polymer.
Porous Uncemented,
21 CFR § 888.3358 |
| Predicate Device: | MAYO Conservative Hip Prosthesis, manufactured
by Zimmer, Inc., K030733, cleared May 1, 2003 |
| Device Description: | Like its predicate, the modified MAYO Conservative
Hip Prosthesis is a modular femoral stem intended
to replace the hip joint in total hip arthroplasty. It is
identical to its predicate in that it features a 12/14
Morse-type taper and uses the same variety of
modular femoral heads. It differs only in overall
size where the design is intended to address smaller
patient anatomies. As with the predicate, the
proposed stem is collarless, wedge-shaped, and is
designed for use without bone cement. Fixation is
achieved by mechanical press fit into the proximal
femoral shaft and by biological ingrowth into the
fiber metal pads. As with the predicate, the
proposed device is available with and without
Calcicoat ® Ceramic Coating (HA/TCP). |
| Intended Use: | The MAYO Conservative Hip Prosthesis is indicated
for cementless use in skeletally mature individuals
undergoing primary surgery for total hip |
*Trademark of Mayo Foundation
.
:
.
1
| | 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 modifications to the MAYO hip change neither
the intended use nor the fundamental scientific
technology of the device. It is packaged,
manufactured and sterilized using the same
materials and processes. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | Engineering evaluations demonstrated that the
device is equivalent to the predicate. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for |
this device.
- Trademark of Mayo Foundation
.
:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
DEC 2 0 2006
Re: K061461 Trade/Device Name: MAY0®* Conservative Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: December 7, 2006 Received: December 8, 2006
Dear Ms. Jenks:
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
3
Page 2 - Ms. Patricia Jenks
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K061461 510(k) Number (if known):
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.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Offic lice Evaluation (ODE)
, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
- Trademark of Mayo Foundation
510(k) Number K061461 Page 1 of 1