(39 days)
The indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, theumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. Standard surgical and rehabilitative procedures are indicted with this device. This device is for use with bone cement.
The Ascent Knee System is a Co-Cr-Mo femoral component, a Ti-6Al-4V tibial component and a UHMWPE tibial bearing designed to replace a damaged or diseased knee joint. Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative joint disease, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. The device is intended for use with bone cement.
The provided text is a 510(k) summary for the Biomet Ascent Knee System, submitted to the FDA in 1998. This document is related to market clearance for a medical device and describes its intended use and establishes substantial equivalence to existing devices.
Crucially, this document describes a medical device, not a software algorithm or AI device. Therefore, the concepts of acceptance criteria related to algorithmic performance, test sets, ground truth, experts, adjudication methods, MRMC studies, standalone performance, and training sets, as requested in the prompt, are not applicable to this type of submission.
This document focuses on:
- Device Description: The physical components of the knee system.
- Indications for Use: The medical conditions the device is intended to treat.
- Potential Risks: General risks associated with joint replacement.
- Substantial Equivalence: Comparing the Ascent Knee System to other legally marketed knee prostheses based on function and overall design. This is the primary "proof" for 510(k) submissions – demonstrating that the new device is as safe and effective as a predicate device.
Therefore, I cannot provide the requested information in a table format as it pertains to algorithmic performance, because the provided text does not contain any such information.
{0}------------------------------------------------
SEP 2 2 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
Ascent Knee System Device:
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (CFR 888,3560)
The Ascent Knee System is a Co-Cr-Mo femoral component, a Ti-Device Description: 6Al-4V tibial component and a UHMWPE tibial bearing designed to replace a damaged or diseased knee joint. Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative joint disease, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. The device is intended for use with bone cement.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
- Reaction to bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/Migration Tissue growth failure
Blood vessel damage Soft tissue imbalance Delaved wound healing Metal sensitivity Fracture of the components Nerve damage
Bone Fracture Infection Hematoma Dislocation Excessive wear
Substantial Equivalence: In function and overall design, Biomet's Ascent Knee System is equivalent to almost all knee components on the market. These include:
AGC 2000 Total Knee Prosthesis (Biomet, Inc., Warsaw, IN) Maxim Knee System (Biomet, Inc., Warsaw, IN) Performance Knee System (Biomet, Inc., Warsaw, IN)
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing health, human services, and prevention. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1998
Mr. Fred McClure Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
K982869 Re: Ascent Knee System Trade Name: Regulatory Class: lı Product Code: JWH Dated: September 14, 1998 Received: September 15, 1998
Dear Mr. McClure:
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, Drug, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 - Mr. Fred McClure
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 regulation (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 Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510 (k) Number (if known) : K9822869
Device Name: Ascent Knee System
Indications For Use: The indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, theumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements.
Standard surgical and rehabilitative procedures are indicted with this device.
This device is for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982869
00007
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.