(16 days)
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Not Found
No
The description focuses solely on the materials, components, and intended use of a conventional knee prosthesis, with no mention of AI or ML technology.
Yes
Explanation: The device is indicated for the relief of pain and restoration of motion due to various knee conditions, which are therapeutic functions.
No
The device description indicates it is a knee prosthesis, which is an implantable medical device used to replace damaged knee joints, not to diagnose a condition. Its indications for use are for relief of pain and restoration of motion due to various knee conditions, not for their diagnosis.
No
The device description clearly details physical components made of cobalt chromium and titanium, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for the knee joint to relieve pain and restore motion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a knee prosthesis (femoral component and augments) made of materials like cobalt chromium and titanium. These are materials used for implants, not for in vitro diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
Therefore, the Ascent Knee System is a medical device, specifically a surgical implant, and 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. This device is for use with bone cement
Product codes
JWH
Device Description
There are two components introduced into the Ascent Knee System which are as follows: the XXL cobalt chrome femoral component and the XXL titanium femoral augments.
Primary Femoral Component
The Ascent primary femoral component is available in either porous or Interlok finishes. The femoral component is composed of cast cobalt chromium (Co-Cr-Mo), conforming to ASTM specification F-75.
Augments
The Ascent Knee System has independent Ti-6A1-4V femoral augments, which are designed to replace damaged or diseased bone. There are two types of augments available, posterior and distal augments. The posterior augments come in 4mm and 8mm thickenesses, while the distal augments are available in 4, 8, and 12mm thicknesses. The posterior and distal augments are available in 6 sizes.
Mentions image processing
Not Found
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
Not Found
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------|---------------------------------------------------------------------------------|
| Contact Person: | Tracy J. Bickel
(219) 372-1761 |
Ascent Knee System Device(s):
Intended 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. This device is for use with bone cement
Classification: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (CFR 888.3560)
Device Description: There are two components introduced into the Ascent Knee System which are as follows: the XXL cobalt chrome femoral component and the XXL titanium femoral augments.
Primary Femoral Component
The Ascent primary femoral component is available in either porous or Interlok finishes. The femoral component is composed of cast cobalt chromium (Co-Cr-Mo), conforming to ASTM specification F-75.
Augments
The Ascent Knee System has independent Ti-6A1-4V femoral augments, which are designed to replace damaged or diseased bone. There are two types of augments available, posterior and distal augments. The posterior augments come in 4mm and 8mm thickenesses, while the distal augments are available in 4, 8, and 12mm thicknesses. The posterior and distal augments are available in 6 sizes.
00090
1
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 disease Fracture of the cement Implant loosening/migration Tissue growth failure
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Nerve damage
Bone fracture Infection Hematoma Dislocation Excessive wear
2
Public Health Service
JAN - 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy J. Bickel Regulatory Specialist Biomet Manufacturing Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K994326
Trade Name: Ascent XXL Primary Femoral Component and XXL Femoral Augments Regulatory Class: II Product Code: JWH Dated: December 17, 1999 Received: December 22, 1999
Dear Ms. Bickel:
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 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). 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 requirements, 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.
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Page 2 - Ms. Tracy J. Bickel
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) 594-4559. 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 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/dsma/dsmamain.html".
Sincerely yours,
,
"Henrich Ley"
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
510(k) Number (if known): _ K994326 Device Name: Ascent Knee System Indications for Use:
The Ascent Knee System is indicated for:
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.
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 | X |
|---|---|
| (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 ________________________________________________________________________________________________________________________
00009