(25 days)
Not Found
Not Found
No
The summary describes a conventional knee prosthesis and does not mention any AI or ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section states that the device is for the "relief of pain and restoration of motion," which are therapeutic benefits.
No
The provided text describes the Ascent Knee, which is a knee prosthesis designed to replace damaged or diseased knee bone. Its purpose is to relieve pain and restore motion, classifying it as a treatment device, not a diagnostic one.
No
The device description explicitly states it includes "independent Ti-6A1-4V femoral augments," which are hardware components.
No, 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 provided text describes a knee prosthesis (an artificial joint) designed to be implanted in the body to replace damaged knee bone.
- Intended Use: The intended use is to relieve pain and restore motion in the knee due to various conditions. This is a therapeutic use, not a diagnostic one.
The Ascent Knee is a medical device, specifically an implantable orthopedic device, not an IVD.
N/A
Intended Use / 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 noninflammatory degenerative joint diseases, rheumatoid 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.
Product codes
JWH
Device Description
The Ascent Knee System has independent Ti-6A1-4V femoral augments which are designed to replace damaged or diseased knee bone. Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative ioint disease, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. The device is intended for use with bone cement.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
MAY 21 1938
SUMMARY OF SAFETY AND EFFECTIVENESS
Biomet, Inc. Sponsor: Airport Industrial Park P.O. Box 587 Warsaw, IN 4681-0587
Ascent Knee System Device:
Classification: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (CFR 888.3560)
Device Description: The Ascent Knee System has independent Ti-6A1-4V femoral augments which are designed to replace damaged or diseased knee bone. Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative ioint 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 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 Delayed would healing Metal sensitivity Fracture of the components Nerve damage
- Bone fracture Infection Hematoma Dislocation Excessive wear
Modifications made were to the Performance Knee femoral augment to produce the Ascent Knee femoral augments.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 1999
Ms. Dalene Hufziger Binkley Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re: K991428 Ascent Knee System Trade Name: Regulatory Class: II Product Code: JWH Dated: April 23, 1999 Received: April 26, 1999
Dear Ms. Binkley:
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 The general controls provisions of the Act 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 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 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.
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Page 2 - Ms. Dalene Hufziger Binkley
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,
Russell P. Vayr
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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Page 1 of 1
510 (k) NUMBER (IF KNOWN): ____
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 noninflammatory degenerative joint diseases, rheumatoid 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.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter-Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
| (Division Sign-Off) Division of General Restorative Devices | |
|---|---|
| 510(k) Number | K991428 |
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