(90 days)
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.
The Interax® Total Knee System consists of a variety of components: Femoral Component, Tibial Baseplate, Tibial Inserts (standard condylar and high conformity condylar, available in two halves), All Polyethylene Patellar Components (resurfacing and inset designs), Femoral Extension Stems, Tibial Extension Stems (cylindrical and cruciform styles), and Tibial Wedges.
The provided text is related to a 510(k) submission for the Interax® Total Knee System, a medical device. This document is a premarket notification for a Class II medical device, indicating that its approval is based on demonstrating substantial equivalence to a predicate device already on the market, rather than new clinical trials demonstrating safety and effectiveness.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way described in the prompt (i.e., with specific performance metrics, sample sizes, expert ground truth, etc.). This type of detailed performance criteria and study results are typically generated for novel devices or those undergoing PMA (Premarket Approval), not for 510(k) submissions that rely on substantial equivalence.
Instead, the document states:
- "Testing was presented in accordance with the FDA Total Knee Guidance Document." This implies that the device met generally accepted testing standards relevant to knee implants (e.g., mechanical, wear, fatigue testing), but the specific acceptance criteria and results are not detailed.
- The FDA's letter confirms substantial equivalence to predicate devices: Duracon® Total Knee System (Howmedica) and Kinemax® Plus Total Knee System (Howmedica).
Therefore, I cannot provide the requested table and detailed study information based on the input text. The prompt's requirements (acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance) are not typically found in a 510(k) summary focused on substantial equivalence.
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510(k) Summary
NOV 1 8 1997
Interax® Total Knee System Device:
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.
The Interax® Total Knee System consists of a variety of components. Each of these components is described below:
Femoral Component 1.
The femoral component is available in left and right configurations, and a range of sizes to match varying patient anatomy. The sizes of the femoral components are grouped into three size ranges.
The internal aspect of the femoral component incorporates a macrotextured ("diamond") surface for cement bonding. There are cement recesses which help ensure an adequate cement mantle. There is a central stem on the component which has a PMMA plug. This plug can be removed to allow the use of femoral stem extensions (described below).
2. Tibial Baseplate
The tibial baseplate is neutral (no lefts/rights), and it is available in a range of sizes to match varying patient anatomy. The sizes of the tibial components are grouped into the same three size ranges as the femoral component.
The superior surface of the tibial baseplate has a central dovetail, an anterior abutment, and medial and lateral tabs. These features form the baseplate portion of the insert-baseplate locking mechanism. There is a hole on the superior aspect of the baseplate that accepts a screw to secure tibial stem extensions.
The undersurface of the tibial baseplate has a short central stem with a PMMA plug which can be removed to allow the optional use of stem extenders (described below). There are fins coming off the stem which run at an angle toward the posterior aspect of the baseplate. These fins provide rotational stability. The undersurface of the baseplate is macrotextured ("diamond") to enhance cement bonding.
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3. Tibial Inserts
The Interax® Tibial Inserts are available in two styles: a standard condylar design, and a high conformity condylar design. The Interax® tibial inserts are available in two halves. This allows the surgeon to evaluate the medial and lateral compartments of the knee individually. The surgeon can utilize different insert thicknesses of up to 2mm between the medial and lateral side of the tibial plateau to compensate for the soft tissue tension observed in the joint.
Both the standard condylar and high conformity condylar inserts are available in four size ranges to accommodate the choice of one size up and one size down interchangeability. The inserts are available in a variety of thicknesses to accomodate varying patient anatomy. The minimum polyethylene thickness of these inserts is 6mm.
All Polyethylene Patellar Components র্বা
There are two styles of all polyethylene patellar components: a resurfacing design and an inset design. Both styles are available in four sizes. Because the radius at the base of the patellar groove of the femoral component remains constant for all sizes of femoral component, all sizes of patellar components can be used with all sizes of femoral components.
5. Femoral Extension Stems
The Femoral Stem Extensions are rod shaped with a rounded end and grooves to enhance cement bonding, and to enhance stability. These stem extensions are screwed into the central stem on the femoral component. These stems are available in varving lengths.
6. Tibial Extension Stems
The tibial extension stems are available in two styles: a cylindrical extension stem, and a cruciform extension stem. The cylindrical stems are rod shaped with rounded ends and grooves to enhance cement bonding and to provide some rotational stability. The cruciform style is a cruciform keel shape that provides rotational stability, but is less invasive. Both styles of extension stems mate with the stem of the tibial baseplate via a Morse taper connection that is augmented by a locking screw.
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Tibial Wedges 7.
The tibial wedges are designed to address bony defects on the medial or lateral aspect of the proximal tibia. These wedges are angled 10°, and are available in varying sizes to match the undersurface of the tibial baseplates. There is a groove in the wedge to allow it to mate with the fins on the undersurface of the tibial baseplate. This wedge is cemented to the baseplate, and then the wedge-baseplate combination is cemented into the proximal tibia.
The Interax® Total Knee System is substantially equivalent to other legally marketed devices: Duracon® Total Knee System (Howmedica) and Kinemax® Plus Total Knee System (Howmedica). Testing was presented in accordance with the FDA Total Knee Guidance Document.
| For information contact: | Margaret F. CroweManager, Regulatory AffairsHowmedica Inc.359 Veterans BoulevardRutherford, NJ 07070(201) 507-7431 |
|---|---|
| Fax: (201) 507-6870 |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Margaret F. Crowe Group Regulatory Affairs Manager Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
NOV 1 8 1997
Re: K973121 Interax® Total Knee System Regulatory Class: II Product Code: JWH Dated: Auqust 19, 1997 Received: August 20, 1997
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. 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 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 regulations.
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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 qeneral 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. Whitton, Ph.D.
ia 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 197312
510(k) Number (if known):
Device Name: Interax® Total Knee System
Indications for Use:
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.
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Concurrence of CDRH, Office of Device Evaluation (ODE) --Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) nal Format 1-2-96) sion Sign-Off ision of General Restorative Devices 516510(k) Number
§ 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.