(90 days)
Duracon® Total Knee System (Howmedica), Kinemax® Plus Total Knee System (Howmedica)
Not Found
No
The summary describes a mechanical implant system for knee replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Therapeutic devices are used to treat illnesses or conditions. This device is a total knee replacement system intended for patients requiring total knee replacement due to various medical conditions like non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis, hence it is a therapeutic device.
No
The Interax® Total Knee System is a prosthetic device intended for total knee replacement, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components (Femoral Component, Tibial Baseplate, Tibial Inserts, etc.) that constitute the Interax® Total Knee System.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The components listed are all parts of a prosthetic knee joint, designed to be implanted in the body.
- No mention of diagnostic testing: There is no indication that this device is used to test samples (blood, tissue, etc.) to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used to treat a condition (damaged knee joint).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Interax® Total Knee System consists of a variety of components as described below:
- Femoral Component: The femoral component is available in left and right configurations, and a range of sizes to match varying patient anatomy. The sizes are grouped into three size ranges. The internal aspect has a macrotextured ("diamond") surface for cement bonding and cement recesses. It has a central stem with a PMMA plug which can be removed for femoral stem extensions.
- Tibial Baseplate: The tibial baseplate is neutral (no lefts/rights), and is available in a range of sizes corresponding to the femoral component sizes. Its superior surface has a central dovetail, an anterior abutment, and medial and lateral tabs for the insert-baseplate locking mechanism. A hole on the superior aspect accepts a screw for tibial stem extensions. The undersurface has a short central stem with a removable PMMA plug for optional stem extenders. Fins coming off the stem run at an angle toward the posterior aspect for rotational stability. The undersurface is macrotextured ("diamond") for cement bonding.
- Tibial Inserts: The Interax® Tibial Inserts come in two styles: a standard condylar design, and a high conformity condylar design. They are available in two halves, allowing evaluation of medial and lateral compartments individually and different insert thicknesses (up to 2mm) between sides. Both styles are available in four size ranges for interchangeability, and various thicknesses. The minimum polyethylene thickness is 6mm.
- All Polyethylene Patellar Components: Two styles are available: a resurfacing design and an inset design, both in four sizes. All patellar component sizes can be used with all femoral component sizes.
- Femoral Extension Stems: These are rod shaped with a rounded end and grooves for cement bonding and stability. They screw into the central stem of the femoral component and are available in varying lengths.
- Tibial Extension Stems: Available in two styles: a cylindrical extension stem and a cruciform extension stem. Cylindrical stems are rod shaped with rounded ends and grooves for cement bonding and some rotational stability. Cruciform style is a cruciform keel shape for rotational stability, being less invasive. Both mate with the tibial baseplate stem via a Morse taper connection augmented by a locking screw.
- Tibial Wedges: Designed to address bony defects on the medial or lateral aspect of the proximal tibia. These wedges are angled 10° and available in varying sizes to match the undersurface of the tibial baseplates. They have a groove to mate with the fins on the tibial baseplate undersurface. The wedge is cemented to the baseplate, and then the wedge-baseplate combination is cemented into the proximal tibia.
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)
Testing was presented in accordance with the FDA Total Knee Guidance Document.
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.
Duracon® Total Knee System (Howmedica), Kinemax® Plus Total Knee System (Howmedica)
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
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.
1
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.
2
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. Crowe
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
(201) 507-7431 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Fax: (201) 507-6870 | |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized human profiles incorporated into the design.
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.
4
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
5
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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