DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

• K Number: K980632
• Device Name: DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION
• Manufacturer: HOWMEDICA CORP.
• Date Cleared: 1998-12-11 ( 295 days)
• Product Code: JWH JDI LPH
• Regulation Number: 888.3560

Intended 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.

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 Duration® II Stabilization. The purpose of the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the gas plasma sterilization process. The Duracon® Condylar and A-P lipped Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA quidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices. As will be discussed later, this additional style of insert demonstrated significantly less wear when compared to air irradiated UHMWPE. 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 mechanism that is identical to those Duracon® inserts which have been previously released.

Predicate Devices

K980626, K980632

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material properties and manufacturing process of a knee implant component, with no mention of AI or ML.

Therapeutic

Yes
The device is a tibial insert used in total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint, thereby restoring function and alleviating pain. This falls under the definition of a therapeutic device as it is intended to treat or alleviate a medical condition.

Diagnostic

No

The device is described as an additional style of Duracon® Condylar and A-P lipped tibial inserts intended for use in total knee arthroplasty, and its description focuses on materials, manufacturing process, and mechanical performance (wear rate), not on diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical implant (tibial inserts made of UHMWPE) and its manufacturing process, not a software product.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states it's for "primary or revision cemented total knee arthroplasty." This is a surgical procedure involving the implantation of a medical device into the body.
• Device Description: The description details a "tibial insert" made of UHMWPE, which is a component of a knee implant. It discusses manufacturing processes, materials, and physical characteristics.
• Anatomical Site: The anatomical site is the "Knee," which is an internal part of the body.
• Performance Studies: The performance studies focus on "wear rate" in a "multiaxial knee joint simulator," which simulates the mechanical forces and wear within a knee joint.

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is an implantable medical device used in vivo (within the body) for surgical reconstruction.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

JDI, LPH, JWH

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 Duration® II Stabilization. The purpose of the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the gas plasma sterilization process. The Duracon® Condylar and A-P lipped Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA quidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices. As will be discussed later, this additional style of insert demonstrated significantly less wear when compared to air irradiated UHMWPE.

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 mechanism that is identical to those 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.

Howmedica's Duration® II Stabilized UHMWPE, Duracon® A-P lipped tibial insert (large ,19mm), exhibited an average total wear of 124.87 ± 15.0 mm3 versus 158.67 ± 11.0 mm3 average total wear for the same insert conventionally gamma sterilized in air. Testing was performed in a multiaxial knee joint simulator for five million cycles using a Duracon® femoral component articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

Key Metrics

Average total wear of 124.87 ± 15.0 mm3 for Duration® II Stabilized UHMWPE versus 158.67 ± 11.0 mm3 for conventionally gamma sterilized in air.

Predicate Device(s)

K980626, K980632

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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DEC 1 1 1998

K980633
510(k) Summary

Duration® II Duracon® Tibial Inserts - Gas Plasma Sterilization Device:

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 Duration® II Stabilization. The purpose of the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the gas plasma sterilization process. The Duracon® Condylar and A-P lipped Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA quidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices. As will be discussed later, this additional style of insert demonstrated significantly less wear when compared to air irradiated UHMWPE.

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 mechanism that is identical to those 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:

• 1. Duration® II products meet all ASTM F 648 specified standards
• 2. Duration® II products have no detectable oxidation as measured by FTIR up to 30 days of accelerated aging at 80° C in air.
• റ്റ് Duration® II products have a higher gel content (crosslinking) than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.

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• 4. Duration® II has a lower tensile modulus than air irradiated UHMWPE. This lower stiffness has demonstrated an increase in contact area and a decrease in contact stress.
• No free radicals are detected in the Duration® II material when analyzed by ട. the ESR technique of the final product.
• Duration® II has a lower wear rate, as measured by knee simulator testing, ୍. than air irradiated UHMWPE. Howmedica's Duration® II Stabilized UHMWPE, Duracon® A-P lipped tibial insert (large ,19mm), exhibited an average total wear of 124.87 ± 15.0 mm3 versus 158.67 ± 11.0 mm3 average total wear for the same insert conventionally gamma sterilized in air. Testing was performed in a multiaxial knee joint simulator for five million cycles using a Duracon® femoral component articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Osteonics 359 Veterans Boulevard Rutherford, NJ 07070 [phone]

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines connecting them. The profiles are arranged vertically, with the top profile slightly larger than the others. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Mr. Frank Maas Manager, Regulatory Affairs Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey

Re : K980626 Duration® II Acetabular Trade Name: Components - Gas Plasma Sterilization K980632 Duration II Tibial Trade Name: Inserts - Gas Plasma Sterilization Regulatory Class: II Product Code: JDI, LPH, and JWH September 18, 1998 Dated: September 18, 1998 Received:

Dear Mr. Maas:

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 Requlations, Title 21, Parts 800 to 895. ਉ 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

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Page 2 - Mr. Frank Maas

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 regulations.

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 requlation (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 devices, 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Whitton, Ph.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Indications for Use

510(k) Number (if known): K980632

Duration® II Duracon® Tibial Inserts - Gas Plasma Sterilization Device Name:

こし・んした いい! いい

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
No
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K900632
510(k) Number