(64 days)
Wright Medical's Converse, BIOPRO's Ceramic TARA Femoral Resurfacing Component, THARIES
Not Found
No
The document describes a mechanical implant for hip resurfacing and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML device submissions.
Yes
The device is described as a "Resurfacing Head" for the femoral head, indicated for non-inflammatory degenerative joint disease (including osteoarthritis and avascular necrosis) and rheumatoid arthritis. It is intended to save the natural femur and provide a new surface for the hip to pivot on, which directly treats a medical condition.
No
This device is a resurfacing head for hip replacement, used for treatment rather than diagnosis. Its function is to provide a new surface for the femoral head in patients with conditions like osteoarthritis or avascular necrosis, which is a therapeutic intervention.
No
The device description clearly states it is a physical implantable device made of cobalt-chrome-molybdenum, designed to be surgically implanted into the femoral head. This is a hardware device, 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. These tests are performed outside of the body.
- Device Description: The Nelson Resurfacing Head is a surgical implant. It is designed to be surgically placed inside the body to replace a damaged part of the hip joint.
- Intended Use: The intended use describes treating degenerative joint diseases and rheumatoid arthritis by providing a new surface for the femoral head. This is a treatment, not a diagnostic test performed on a sample.
The description clearly indicates a device that is implanted within the body for therapeutic purposes, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nelson Resurfacing Head is indicated for use in: - a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis - b.) rheumatoid arthritis The Nelson Resurfaced Heads are intended for cemented application and for single use implantation.
Product codes
KXA
Device Description
This device is design to save the natural femur and provide a new surface on the femoral head for the hip to pivot on. The natural acetabulum will remain intact. The device will be manufactured out of cobalt-chrome-molybdenum. This device is intended for use with those who have had significant osteonecrosis of the femoral head. This procedure is limited to treating the diseased portion of the joint without violating the femoral canal with the stem of prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head (hip joint)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wright Medical's Converse, BIOPRO's Ceramic TARA Femoral Resurfacing Component, THARIES
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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR:
Biomet. Inc. P. O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587
CONTACT PERSON: Julie K Ryan
Nelson Resurfacing Head DEVICE:
CLASSIFICATION NAME: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. 888.3400
INTENDED USE: The Nelson Resurfacing Head is indicated for use in:
- a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b.) rheumatoid arthritis
The Nelson Resurfaced Heads are intended for cemented application and for single use implantation.
DEVICE DESCRIPTION: This device is design to save the natural femur and provide a new surface on the femoral head for the hip to pivot on. The natural acetabulum will remain intact. The device will be manufactured out of cobalt-chrome-molybdenum. This device is intended for use with those who have had significant osteonecrosis of the femoral head. This procedure is limited to treating the diseased portion of the joint without violating the femoral canal with the stem of prosthesis.
POTENTIAL RISKS: The potential risk associated with this device is the same as with any joint resurfacing device. These include but are not limited to:
Fracture of the component Cardiovascular disorders Implant loosening /migration Soft tissue imbalance Deformity of the joint Tissue growth failure Delayed wound healing Metal sensitivity
Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation
SUBSTANTIAL EQUIVALENCE: The Nelson Resurfacing Head is substantially equivalent to most head replacement devices on the market in overall function and design. Predicate devices are Wright Medical's Converse and BIOPRO's Ceramic TARA Femoral Resurfacing Component and THARIES.
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 1998
Ms. Mary Verstynen Regulatory Affairs Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K983452 Nelson Resurfacing Head Requlatory Class: İI Product Code: KXA Dated: September 28, 1998 Received: September 30, 1998
Dear Ms. Verstynen:
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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Mary Verstynen
This letter will allow you to begin marketing your device as described in your 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 requlation (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 or (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 Dorico Faluation
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(K) NUMBER IF KNOWN: DEVICE NAME: The Nelson Resurfacing Head
The indications for use are:
- a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b.) rheumatoid arthritis
The Nelson Resurfacing Head is cemented femoral component and is a single use implant.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Division Sign-Off
or Over the Counter-Use
(Optional Optional Format 1-2-96)
Division of General Restorative Devices 510(k) Number
Image /page/3/Picture/11 description: The image shows the number 00302. The numbers are in a bold, sans-serif font. The numbers are black against a white background.