DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION

K980926 · Howmedica Corp. · JDI · Dec 16, 1998 · Orthopedic

Device Facts

• Record ID: K980926
• Device Name: DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
• Applicant: Howmedica Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of this additional style of System 12® acetabular inserts is identical to that of previously released System 12® inserts: they are intended to be used with Osteolock/Vitalock acetabular shells in primary or revision total hip arthroplasty.

Device Story

Duration® II System 12® Acetabular Inserts are orthopedic implants for total hip arthroplasty. UHMWPE rod stock undergoes gamma radiation cross-linking in low-oxygen environments followed by heat stabilization to eliminate free radicals. Machined inserts are terminally sterilized via ethylene oxide. Used in primary or revision hip surgery; implanted by orthopedic surgeons. The device mates with Osteolock/Vitalock acetabular shells and Howmedica femoral heads. Cross-linking process increases gel content, reduces tensile modulus, increases contact area, and decreases contact stress compared to air-irradiated UHMWPE. Benefits include reduced wear rates, potentially extending implant longevity.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance on UHMWPE. Hip wear simulator testing (5 million cycles, 32mm CoCr head, bovine calf serum) showed average total wear of 198.60 ± 31.9 mm³ for Duration® II vs 310 ± 40.8 mm³ for air-irradiated UHMWPE. Material properties verified via FTIR (no detectable oxidation after 30 days accelerated aging at 80°C) and modified ASTM D2765-90 (higher gel content). ESR technique confirmed no detectable free radicals.

Technological Characteristics

Material: UHMWPE conforming to ASTM F-648. Process: Gamma radiation cross-linking, heat stabilization, ethylene oxide sterilization. Design: Neutral, 10°, and 15° hooded configurations; various outer diameters and 22.0-32mm inner diameters. Mechanical properties: Lower tensile modulus and higher gel content than air-irradiated UHMWPE.

Indications for Use

Indicated for patients undergoing primary or revision total hip arthroplasty requiring acetabular inserts to be used with Osteolock/Vitalock acetabular shells.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• System 12® acetabular liners (Howmedica)

Submission Summary (Full Text)

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## K980926

DEC 16 1998

## 510(k) Summary

Duration® II System 12® Acetabular Inserts - Ethylene Oxide Sterilization Device:

The purpose of this submission is to describe an additional style of System 12® acetabular Inserts which are stabilized/sterilized using a process called Duration® II Stabilization. The purpose of the Duration® If 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 acetabular insert is packaged in air, and terminally sterilized by the ethylene oxide sterilization process. The System 12® Acetabular Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA guidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices.

The intended use of this additional style of System 12® acetabular inserts is identical to that of previously released System 12® inserts: they are intended to be used with Osteolock/Vitalock acetabular shells in primary or revision total hip arthroplasty.

These System 12® inserts are identical in design to the previously cleared System 12® inserts: they are available in a range of outer diameter sizes to mate with the respective acetabular shell, and 22.0, 22.2, 26, 28, and 32mm inner diameters to mate with Howmedica femoral heads. These inserts are available in a neutral, 10°, and 15° hooded design. The locking mechanism of this style of acetabular insert is identical to the previously released System 12® acetabular inserts.

These inserts are substantially equivalent to the other System 120 acetabular liners 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.
- Duration® II products have no detectable oxidation as measured by FTIR up to 2. 30 days of accelerated aging at 80° C in air.
- 3. Duration® II products have a higher gel content (cross-linking) than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.
- Duration® II has a lower tensile modulus than air irradiated UHMWPE. This যঁ lower stiffness has demonstrated an increase in contact area and a decrease in contact stress.

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- No free radicals are detected in the Duration® II material when analyzed by 5. the ESR technique of the final product.
- Duration® II has a lower wear rate, as measured by hip wear simulator than air 6. irradiated UHMWPE (an average total wear of 198.60 ± 31.9 mm³ instead of 310 ± 40.8 mm³). Testing was performed in a multiaxial hip joint simulator for five million cycles using a 32 mm CoCr head 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.

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 1998

Ms. Margaret Crowe Manager, Requlatory Affairs Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re : K980925 Duration® II Tibial Inserts - EtO Trade Name: Sterilization K980926 Duration® II Acetabular Components - EtO Trade Name: Sterilization Requlatory Class: II Product Codes: JWH and JDI Dated: October 7, 1998 Received: October 8, 1998

Dear Ms. Crowe:

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. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturinq Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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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Paqe 2 - Ms. Margaret Crowe

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 requlations.

This letter will allow you to beqin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosures

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## Indications for Use

510(k) Number (if known): K980926

Device Name: Duration® II System 12® Acetabular Inserts, Ethylene Oxide Sterilization

Indications for Use:

The intended use of this additional style of System 12® acetabular inserts is identival The Intention use of this additional or to of of of of of of the need with to that of provided foremously of evision total hip arthroplasty.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Division Sign Org.

eneral Restorative Devic