(280 days)
Not Found
Not Found
No
The description focuses on the material properties, manufacturing process, and physical characteristics of a knee implant component. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a tibial insert used in total knee arthroplasty, which is a medical procedure to treat a condition (e.g., severe arthritis) and improve function, thus fitting the definition of a therapeutic device.
No
The device description indicates that the device is a tibial insert, which is a component of a total knee arthroplasty, and its purpose is structural (to provide joint articulation), not diagnostic.
No
The device description clearly describes a physical implant (tibial inserts made of UHMWPE) used in knee surgery, not a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "primary or revision cemented total knee arthroplasty." This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a physical implant made of Ultra High Molecular Weight Polyethylene (UHMWPE) designed to be inserted into the knee joint. This is consistent with a medical device used for surgical implantation, not an IVD.
- Anatomical Site: The anatomical site is the "knee," which is a part of the human body where a surgical implant would be placed.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
Therefore, this device is a surgical implant used in knee replacement surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Intended use of this additional style of Duracon® Condylar and A-P lipped tibial inserts is identical to that of previously released Duracon® tibial inserts: they are intended to be used with Duracon® femoral and patellar components, and tibial baseplates in primary or revision cemented total knee arthroplasty.
Product codes
JWH, JDI
Device Description
The purpose of this submission is to describe an additional style of Duracon® Condylar and A-P lipped tibial inserts which are stabilized/sterilized using a process called and A-1 "Ilpped tible incorro the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation this froo radio lound lount in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized periou, the United to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the ethylene oxide sterilization process. The Duracon® and terminally ottomized by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, for Okla Figh Molocation on UHMWPE used in Bearing Surfaces for Orthopedic Devices.
These Duracon® Condylar and A-P lipped inserts are identical to those previously released. They are available in peripheral sizes extra-small through extra-large in thicknesses from 6mm to 25mm. These inserts have a three point locking in thisklesson from on on on one Duracon® inserts which have been previously released.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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
Testing was performed in accordance with the draft FDA guidance on UHMWPE.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K980925
DEC 16 1998
510(k) Summary
Device:
Duration® II Duracon® Tibial Inserts - Ethylene Oxide Sterilization
The purpose of this submission is to describe an additional style of Duracon® Condylar and A-P lipped tibial inserts which are stabilized/sterilized using a process called and A-1 "Ilpped tible incorro the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation this froo radio lound lount in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized periou, the United to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the ethylene oxide sterilization process. The Duracon® and terminally ottomized by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, for Okla Figh Molocation on UHMWPE used in Bearing Surfaces for Orthopedic Devices.
The intended use of this additional style of Duracon® Condylar and A-P lipped tibial inserts is identical to that of previously released Duracon® tibial inserts: they are intended to be used with Duracon® femoral and patellar components, and tibial baseplates in primary or revision cemented total knee arthroplasty.
These Duracon® Condylar and A-P lipped inserts are identical to those previously released. They are available in peripheral sizes extra-small through extra-large in thicknesses from 6mm to 25mm. These inserts have a three point locking in thisklesson from on on on one Duracon® inserts which have been previously released.
These inserts are substantially equivalent to the other Duracon® Condylar and A-P lipped tibial Inserts which are already in distribution by Howmedica.
Testing was performed in accordance with the draft FDA guidance on UHMWPE.
The following marketing claims will be made for the product:
- Duration® II products meet all ASTM F 648 specified standards. 1.
- Duration® II products have no detectable oxidation as measured by FTIR up to 2. 30 days of accelerated aging at 80° C in air.
- Duration® II products have a higher gel content (cross-linking) than air irradiated న. UHMWPE measured in accordance with modified ASTM D2765-90 standard.
1
-
Duration® II has a lower tensile modulus than air irradiated UHMVE. This 4. Duranone if had a lower tonelle would increase in contact area and a decrease in contact stress.
-
No free radicals are detected in the Duration® II material when analyzed by ട്. the ESR technique of the final product.
Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Osteonics 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7875
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized, curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 1998
Ms. Margaret Crowe Manager, Regulatory Affairs Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re : K980925 Duration® II Tibial Inserts - EtO Trade Name: Sterilization K980926 Duration® II Acetabular Components - EtO Trade Name: Sterilization Regulatory Class: II Product Codes: JWH and JDI October 7, 1998 Dated: Received: October 8, 1998
Dear Ms. Crowe:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 Failure to Administration (FDA) will verify such assumptions.
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Page 2 - Ms. Margaret Crowe
In addition, FDA may publish further announcements action. concerning your devices 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 requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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,
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
Indications for Use
510(k) Number (if known): K980925
Device Name: Duration® II Duracon® Tibial Inserts - Ethylene Oxide Sterilization
Indications for Use:
The Intended use of this additional style of Duracon® Condylar and A-P lipped tibial
. The Internet in the form involvareleased Duracen® tibial inserts , they are The Intended use of this buttonial style of eleased Duracon® tibial inserts: they are
inserts is identical to the Describers of and only and seteller components, and tibial inserts is identical to that of proviously toroloos Datellar components, and tibial
intended to be used with Duracon® femoral and patellar components, and tibial intended to be used with Burace. IS formers of the knee arthroplasty.
The seplates in primary or revision cemented total knee arthroplasty.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
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