DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS

K972792 · Howmedica Corp. · JDI · Oct 16, 1997 · Orthopedic

Device Facts

• Record ID: K972792
• Device Name: DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
• Applicant: Howmedica Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Exeter All Plastic Acetabular Component (previously cleared in K936132) is intended to be used for primary and secondary reconstruction of the bearing surface of the acetabulum as a result of painful and/or severly disabled hip joints due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or revision of a failed acetabular component. The Howmedica® Bipolar Prosthesis, Centrax® (previously cleared in K855231) is intended to be used in conjunction with a femoral stem component for the reconstruction of a femoral head damaged by fresh fracture, non-union, aseptic necrosis of the head and neck, or by osteoarthritis or post-traumatic arthritis.

Device Story

Duration® Stabilized UHMWPE acetabular components are orthopedic implants designed for hip arthroplasty. The device utilizes an ultra-high molecular weight polyethylene (UHMWPE) material subjected to a proprietary 'Duration® Stabilized' process, which serves as an alternative to standard air-irradiated gamma sterilization. The device is intended for use by orthopedic surgeons in clinical settings for hip joint reconstruction. The primary clinical benefit is a reduction in volumetric wear compared to conventionally gamma-sterilized components, as demonstrated in in vitro hip joint simulator testing. The device is used in conjunction with femoral stem components and CoCr articulating counterfaces. Surgeons utilize these components to restore joint function and alleviate pain in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided. Evidence consists of bench-only in vitro testing using a multiaxial hip joint wear simulator. Testing involved over 5 to 10 million cycles using CoCr heads and bovine calf serum lubricant. Results showed a 27% to 40% reduction in volumetric wear compared to conventionally gamma-sterilized controls. The document explicitly states that in vitro test results have not been shown to correlate with clinical wear mechanisms.

Technological Characteristics

Material: Duration® Stabilized UHMWPE. Components: Exeter All Plastic Acetabular Component and Centrax® Bipolar Prosthesis. Sterilization: Duration® Stabilized process (alternative to air-irradiated gamma). Testing: Multiaxial hip joint wear simulator, CoCr articulating counterfaces, bovine calf serum lubricant.

Indications for Use

Indicated for patients requiring hip reconstruction due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, revision of failed acetabular components, femoral head fracture, non-union, or aseptic necrosis of the femoral head and neck.

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

• Duration® Stabilized process (K934060)
• Exeter All Plastic Acetabular Component (K936132)
• Howmedica® Bipolar Prosthesis, Centrax® (K855231)
• Wear claims (K963612)

Submission Summary (Full Text)

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510(k) Summary

K972792

Proprietary Name: Duration® Stabilized UHMWPE Acetabular Components

Common Name: UHMWPE Acetabular Components

21 CFR 888.3358 Classification Name and Reference:

Proposed Requlatory Class: Class II Device Product Code: JDI

:

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] Fax: [phone] Date Summary Prepared: 7-25-97

This submission describes additional UHMWPE acetabular components that can be sterilized by the Duration® Stabilized process previously cleared in submission K934060, as an alternate to standard air irradiated gamma sterilization. The additional components are the Exeter All Plastic Acetabular Component (K936132) and the Howmedica® Bipolar Prosthesis, Centrax® (K855231). Corresponding wear claims, previously cleared in submission K 963612 and listed below, are also applicable to these additional components.

Howmedica's Duration® Stabilized UHMWPE, System 12®, size P4, neutral acetabular inserts, with an inner diameter of 32mm, a bearing thickness of 6.1 mm and aged for 6 months in an oxygen environment, showed a 36% reduction in volumetric wear versus the same cup conventionally gamma sterilized and aged for 6 months in an oxygen environment. Testing was performed in a multiaxial hip joint simulator for over 10 million cycles, using a 32mm 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.

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Howmedica's Duration® Stabilized UHMWPE, a hemispherical cup of generic design for hip simulator testing, with an inner diameter of 32 mm, and a bearing thickness of 8.4 mm, showed a 40% reduction in volumetric wear versus the same cup conventionally gamma sterilized. Testing was performed in a multiaxial hip joint wear simulator for over 5 million cycles, using a 32 mm diameter CoCr Head articulating counterface and tow calcium" containing bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

Howmedica's Duration® Stabilized UHMWPE, System 12® Neutral Acetabular Insert, size P4. with an inner diameter of 32mm, and a bearing thickness of 6.1 mm, showed a 40% reduction in volumetric wear versus the same cup conventionally gamma sterilized. Testing was performed in a hip joint wear simulator for over 5 million cycles, using a 32 mm CoCr Head articulating counterface and high calcium" containing bovine calf serum as a lubricant. The results of these in vitro tests have not been shown to correlate with clinical wear mechanisms or in vitro third body wear mechanisms involving fragments of bone cement, UHMWPE , metal, ceramic, etc.

In an independent laboratory test on Howmedica's Duration® Stabilized UHMWPE, a hemispherical cup of generic design for hip simulator testing, with an inner diameter of 32 mm, a bearing thickness of 8.4 mm, and having undergone 11 days of heating in air to simulate 5 years "aging", showed a 27% reduction in volumetric wear versus the same cup conventionally gamma sterilized, having undergone 11 days of heating in air to simulate 5 years "aging". Testing was performed in a multiaxial hip joint wear simulator over 10 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank Maas .Manager, Requlatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070

OCT 1 6 1997

Re: K972792 Duration Stabilized UHMWPE Exeter All Trade Name: Plastic Acetabular Component and Centrex® Bipolar Component Regulatory Class: II Product Codes: JDI and KWY Dated: July 25, 1997 Received: July 28, 1997

Dear Mr. Maas:

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 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 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 Regulations, 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 General regulation (21 CFR Part 820) and that, Devices: 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Frank Maas

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 enrough on or or on control provisions, or other Federal laws or regulations.

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.qov/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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ications for Use

510(k) Number (if known):

Device Name: Duration® Stabilized UHMWPE Acetabular Components

Indications for Use:

The Exeter All Plastic Acetabular Component (previously cleared in K936132) is intended to be used for primary and secondary reconstruction of the bearing surface of the acetabulum as a result of painful and/or severly disabled hip joints due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or revision of a failed acetabular component.

The Howmedica® Bipolar Prosthesis, Centrax® (previously cleared in K855231) is intended to be used in conjunction with a femoral stem component for the reconstruction of a femoral head damaged by fresh fracture, non-union, aseptic necrosis of the head and neck, or by osteoarthritis or post-traumatic arthritis.

SEE NEXT PAGE FOR DURATION® WEAR CLAIMS

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use | |
|----------------------|---|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |

(Division Sign-Off)

D - General Restorative Devices

510(k) K972792 (Optional Format 1-2-96)