FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM

K980713 · Howmedica Corp. · JWH · May 22, 1998 · Orthopedic

Device Facts

• Record ID: K980713
• Device Name: FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM
• Applicant: Howmedica Corp.
• Product Code: JWH · Orthopedic
• Decision Date: May 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Interax® femoral and tibial plugs; accessory components for Interax® Total Knee System. Plugs occlude internal threaded portion of femoral stem and internal taper of tibial component; removable to allow optional stem extensions. Fabricated from Rohm & Haas acrylic resin; replaces previous pellitized PMMA (Simplex P) material. Used by orthopedic surgeons in clinical/OR settings during total knee arthroplasty. Device provides physical occlusion of stem cavities; facilitates cemented fixation. Benefit: maintains system modularity and component integrity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Femoral and tibial plugs made of acrylic resin (Rohm & Haas). Mechanical occlusion device. No energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for patients requiring cemented primary or revision total knee arthroplasty due to non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Requires intact posterior cruciate ligament (or accommodation), and intact/reparable collateral ligaments or adequate capsular support for stability.

Regulatory Classification

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).

Predicate Devices

• Interax® Total Knee System (K973121)

Submission Summary (Full Text)

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K980713

## 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 [phone]

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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| Concurrence of CDRH, Office of Device Evaluation | |
|--------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K980713 |
| Prescription Use<br>(Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use | |

(Optional Format 1-2-96)