(26 days)
Not Found
No
The summary describes a mechanical implant made of cobalt alloy with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implant designed to replace the outer surface of the femoral head for conditions like osteoarthritis and rheumatoid arthritis, which are forms of degenerative joint disease. This direct intervention to treat or alleviate a medical condition classifies it as a therapeutic device.
No
The device description clearly states it is a "single use implant intended for use with bone cement" and is "designed to replace the outer surface of the femoral head," indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical implant made from cobalt alloy, designed to replace the outer surface of the femoral head. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "single use implant intended for use with bone cement" and is designed to "replace the outer surface of the femoral head." This is a surgical implant, not a test performed on a sample outside the body.
- Intended Use: The intended use describes treating "degenerative joint disease" and "Rheumatoid arthritis" by replacing a part of the hip joint. This is a therapeutic intervention, not a diagnostic test.
Therefore, this device falls under the category of a medical device implant rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Non-inflammatory degenerative joint disease, including osteoarthritis and a) avascular necrosis
b) Rheumatoid arthritis
The device is a single use implant intended for use with bone cement
Product codes
KXA
Device Description
The Cemented Femoral Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip).
The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a grit blasted (roughened) inner surface identical to the predicate device. A central post has been added for stabilization. The modified device is available in diameters of form 38mm to 60mm, in one-millimeter increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head
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)
Non-Clinical and Clinical Testing: None provided
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
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.
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JUN 2 6 2002
K021799 page 171
Image /page/0/Picture/2 description: The image shows the logo for Biomet, a medical device company. The logo is in black and white and features the word "BIOMET" in a stylized font. Below the logo, the words "CORPORATE HEADQUARTERS" are written in a smaller font. The logo is simple and modern, and it conveys a sense of professionalism and innovation.
Summary of Safety and Effectiveness
| Applicant/Sponsor: | Biomet Orthopedics, Inc. |
|---|---|
| P.O. Box 587 | |
| Warsaw, Indiana 46581-0578 |
Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist Phone: (574) 267-6639 Fax: (574) 372-1790
Trade Name: Cemented Femoral Head Resurfacing Device
Common Name: Hemi-hip
Classification Name: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis (21 CFR 888.3400)
Legally Marketed Device to which Substantial Equivalence is claimed: The current device is a modification of the Nelson resurfacing Head cleared by 510(k) K983452.
Device Description: The Cemented Femoral Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip).
The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a grit blasted (roughened) inner surface identical to the predicate device. A central post has been added for stabilization. The modified device is available in diameters of form 38mm to 60mm, in one-millimeter increments.
Intended Use: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis and rheumatoid arthritis.
Summary of Technologies: The materials, surface finishes and processing of the Cemented Femoral Head Resurfacing Device are similar to the predicate.
Non-Clinical and Clinical Testing: None provided
SHIPPING ADDRESS MAILING ADDRESS P.O. Box 587 56 E. Bell Drive Warsaw, IN 46582 Warsaw, IN 46581-0587 OFFICE FAX
E . 219.267.8137 219.267.6639
l-
E-MAIL biomet@biomet.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockviļle MD 20850 -
JUN 2 6 2002
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedic, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K021799
Trade/Device Name: Cemented Femoral Head Resurfacing Device Regulation Number: 21 CFR 888.3400 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Resurfacing Prosthesis Regulatory Class: Class II Product Code: KXA Dated: May 29, 2002 Received: May 31, 2002
Dear Ms. Beres:
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 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.
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Page 2 - Ms. Patricia Sandborn Beres
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division i 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 N Millman
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
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510(k) Number (if known):
Cemented Femoral Head Resurfacing Device Device Name:
Indications For Use:
- Non-inflammatory degenerative joint disease, including osteoarthritis and a) avascular necrosis
- b) Rheumatoid arthritis
The device is a single use implant intended for use with bone cement
Mark A. Milliman
Division Sign-C Division of General. Restorative and Neurological Devices
021799 510(k) Number_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use n (Per 21 CFR 801.109) OR
Over-The-Counter Use /A
(Optional Format 1-2-96)
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