(87 days)
Not Found
No
The device description focuses on material changes to existing components of a knee replacement system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a total knee system, specifically prosthetic components for knee replacement, which is a therapeutic intervention for various knee joint diseases and trauma.
No
The Interax® Total Knee System is a prosthetic device for total knee replacement procedures, not a device used to identify or diagnose a condition.
No
The device description clearly describes physical components (femoral component, tibial baseplate, PMMA plug) which are hardware, not software.
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 total knee replacement. This is a therapeutic device used in vivo (within the body) to replace a damaged joint.
- Device Description: The description details the components of a knee implant (femoral component, tibial baseplate, PMMA plug) and their materials. These are physical components designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Interax® femoral component and tibial baseplate previously cleared in K 973121 are made available with a PMMA plug inserted onto their central stems. The purpose of this plug is to occlude the internal threaded portion of the central stem of the femoral component and the internal taper surface of the tibial component. The PMMA plug can also be removed to allow the optional use of stem extensions. The current femoral and tibial plugs are fabricated from pellitized PMMA (Simplex P). The new femoral and tibial plugs will be made from a acrylic resin which is supplied by Rohm & Haas.
There is no change in the intended use of the femoral and tibial components of the Interax® Total Knee System - The Interax® Total Knee System is intended to be used in cemented primary and/or revision total knee arthroplasty procedures in patients who require total knee replacement as a result of non-inflammatory joint disease and all of its variants, inflammatory joint disease, trauma, or failed previous prosthesis. The Interax® system is intended to accommodate the posterior cruciate ligament if it is intact. The collateral ligaments should be intact, or reparable, or there must be adequate capsular support to provide medio-lateral stability. The Interax® Total Knee System is intended to be implanted using bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Interax® femoral component and tibial baseplate previously cleared in K973121 are made available with a PMMA plug inserted onto their central stems. The purpose of this plug is to occlude the internal threaded portion of the central stem of the femoral component, and the internal taper surface of the tibial component. The PMMA plug can also be removed to allow the optional use of stem extensions. The current femoral and tibial plugs are fabricated from pellitized PMMA (Simplex P). The new femoral and tibial plugs will be made from a acrylic resin which is supplied by Rohm & Haas.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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.
0
510(k) Summary
Device: Interax® Femoral and Tibial Plugs - Alternate Material
The Interax® femoral component and tibial baseplate previously cleared in K973121 are made available with a PMMA plug inserted onto their central stems. The purpose of this plug is to occlude the internal threaded portion of the central stem of the femoral component, and the internal taper surface of the tibial component. The PMMA plug can also be removed to allow the optional use of stem extensions. The current femoral and tibial plugs are fabricated from pellitized PMMA (Simplex P). The new femoral and tibial plugs will be made from a acrylic resin which is supplied by Rohm & Haas.
There is no change in the intended use of the femoral and tibial components of the Interax® Total Knee System - The Interax® Total Knee System is intended to be used in cemented primary and/or revision total knee arthroplasty procedures in patients who require total knee replacement as a result of non-inflammatory joint disease and all of its variants, inflammatory joint disease, trauma, or failed previous prosthesis ... The Interax® system is intended to accommodate the posterior cruciate ligament if it is intact. The collateral ligaments should be intact, or reparable, or there must be adequate capsular support to provide medio-lateral stability. The Interax® Total Knee System is intended to be implanted using bone cement.
For information contact:
Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070 (201) 507-7431
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a family.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 1998
Ms. Margaret F. Crowe Group Regulatory Affairs Manager Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K980713 Re: Femoral and Tibial Plugs of Interax® Total Knee System Regulatory Class: II Product Code: JWH February 23, 1998 Dated: February 24, 1998 Received:
Dear Ms. Crowe:
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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Ms. Margaret F. Crowe
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
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Indications for Use
510(k) Number (if known):
Device Name: Interax® Femoral and Tibial Plugs - Alternate material
Indications for Use:
The Interax® femoral component and tibial baseplate previously cleared in K 973121 are made available with a PMMA plug inserted onto their central stems. The purpose of this plug is to occlude the internal threaded portion of the central stem of the femoral component and the internal taper surface of the tibial component. The PMMA plug can also be removed to allow the optional use of stem extensions. The current femoral and tibial plugs are fabricated from pellitized PMMA (Simplex P). The new femoral and tibial plugs will be made from a acrylic resin which is supplied by Rohm & Haas.
There is no change in the intended use of the femoral and tibial components of the Interax® Total Knee System - The Interax® Total Knee System is intended to be used in cemented primary and/or revision total knee arthroplasty procedures in patients who require total knee replacement as a result of non-inflammatory joint disease and all of its variants, inflammatory joint disease, trauma, or failed previous prosthesis. The Interax® system is intended to accommodate the posterior cruciate ligament if it is intact. The collateral ligaments should be intact, or reparable, or there must be adequate capsular support to provide medio-lateral stability. The Interax® Total Knee System is intended to be implanted using bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K980713 |
| Prescription Use | |
| (Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use |
(Optional Format 1-2-96)