TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE

K990135 · Zimmer, Inc. · LPH · Jul 12, 1999 · Orthopedic

Device Facts

• Record ID: K990135
• Device Name: TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trilogy Acetabular System Longevity Crosslinked Polyethylene Liners are intended to be used with Trilogy Acetabular Shells and Zimmer femoral stems and heads in cemented or uncemented use in total hip arthroplasty.

Device Story

Modular acetabular component for total hip arthroplasty; utilizes highly crosslinked, thermally stabilized, calcium stearate-free UHMWPE liners. Device functions as articulating bearing surface for femoral component. Manufactured via electron beam irradiation to induce crosslinking, followed by thermal stabilization and gas plasma sterilization. Designed to reduce wear compared to conventional gamma-sterilized UHMWPE. Used by orthopedic surgeons in clinical settings. Performance validated via in vitro hip simulator testing (AMTI and Shore Western) against cobalt-chrome counterfaces; ESR spectroscopy used to confirm absence of residual free radicals, indicating reduced oxidation potential. Benefits include improved wear resistance in hip replacement procedures.

Clinical Evidence

Bench testing only. No clinical data provided. In vitro wear testing performed on hip simulators (AMTI and Shore Western) to 3-5 million cycles using bovine serum lubricant and cobalt-chrome counterfaces. Results demonstrated an average 89% gravimetric wear reduction compared to conventionally gamma-sterilized controls. ESR spectroscopy confirmed undetectable residual free radicals (detection limit 10^13 spins/gram). Note: In vitro results have not been shown to correlate with clinical wear mechanisms.

Technological Characteristics

Material: Compression-molded, calcium stearate-free UHMWPE. Processing: Electron beam crosslinking, thermal stabilization, gas plasma sterilization. Component: Modular acetabular liner for use with Trilogy shells and Zimmer femoral components. Evaluation: ESR spectroscopy for free radical detection; hip simulator wear testing.

Indications for Use

Indicated for skeletally mature individuals undergoing surgery for rehabilitating hips damaged by noninflammatory degenerative joint disease (NIDJD), including osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, and diastrophic variant. Use is cemented or noncemented.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Trilogy® Acetabular System (K934765)
• Trilogy® Acetabular System, 36 mm Liners (K953490)
• Trilogy® Acetabular System, 7 mm Offset Liners (K954698)

Submission Summary (Full Text)

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K990135

P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131

### Summary of Safety and Effectiveness

#### Submitted By: (

JUL 112 1999

Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 219-267-6131

#### Contact Person: t

Karen Cain Regulatory Affairs Associate Telephone: [phone] Telefax:

Date: .

June 23, 1999

#### Trade Name: .

Trilogy® Acetabular System Longevity® Crosslinked Polyethylene Liners

#### Common Name: t

Acetabular Component for Hip Prosthesis

#### Classification Name: ●

Hip Joint Metal/Polymer/Metal Semiconstrained Porous-Coated Uncemented Prosthesis

- Predicate Devices:
- Trilogy® Acetabular System, K934765, cleared April 29, 1994 -

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# Summary of Safety and Effectiveness (Continued)

- Trilogy® Acetabular System, 36 mm Liners, K953490, cleared October 20. 1995
- Trilogy® Acetabular System, 7 mm Offset Liners, K954698, cleared January 17, 1996

### Device Description

The Trilogy Acetabular System Longevity Crosslinked Polyethylene Liners are modular, acetabular components of the same design, geometry, material, and intended use which was previously cleared in premarket notification K934765, This premarket notification contains wear test data of electron beam irradiated UHMWPE components to substantiate claims of improved wear properties due to the change in processing of the devices.

Trilogy Acetabular System Longevity® Crosslinked Polyethylenc Liners showed an average 89 percent gravimetric wear reduction compared to the same cup conventionally gamma sterilized and both nonaged (final product after sterilization) and accelerated aged. The neutral liners (32 mm D/48 mm OD, 5.3 mm thickness and 22 mm ID/36 mm OD, 4.3 mm thickness) were made from compression molded, calcium stearate free UHMWPE were highly crosslinked, thermal stabilized, then gas plasma sterilized both nonaged (final product after sterilization) and accelerated aged. All control and crosslinked liners that were accelerated aged were subjected to 73 psi of oxygen at 70°C for two weeks. Testing was performed to 5 million cycles using an AMTI hip simulator at 1 Hz, a cobaltchrome articulating counterface, and bovine serum as lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

Trilogy Acetabular System Longevily Crosslinked Polyethylene Liners showed an average 89 percent gravimetric wear reduction compared to the same cup conventionally gamma sterilized and accelerated aged when evaluated under abrasive wear conditions. The neutral liners (32 mm ID/48 mm OD. 5.3 mm thickness and 22 mm ID/36 mm OD, 4.3 mm thickness) were made from compression molded, calcium stearate free UHMWPE were highly crosslinked, thermal stabilized, and gas plasma sterilized. The liners were subjected to accelerated aging. Testing was performed to 3 million cycles using a Shore Western orbital-type hip simulator at 1Hz, a cobalt-chrome articulating counterface, and bovine serum as lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

Zimmer highly crosslinked, thermally stabilized UHMWPE, in both accelerated

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# Summary of Safety and Effectiveness (Continued)

aged and nonaged (final product after sterilization) conditions, was evaluated by Electron Spin Resonance (ESR) spectroscopy to determine residual free radicals. The experimental detection limit is estimated to be 1043 spins/gram. In all cases, the residual free radical content was underectable. Reduced levels of free radicals are associated with decreased oxidation of the material.

# Intended Use

The Trilogy Acetabular System Longevity Crosslinked Polyethylene Liners are intended to be used with Trilogy Acetabular Shells and Zimmer femoral stems and heads in cemented or uncemented use in total hip arthroplasty.

### Comparison to Predicate Devices

The predicate devices listed above are substantially equivalent to each other and the Trilogy Acetabular System Longevity Crosslinked Polycthylene Liners in that each is a component of a system that is intended to be implanted into the human acetabulum. All predicate devices and the new device are manufactured from UHMWPE which serves as the articulating bearing surface for the femoral component.

### RA01901K.510.DOC

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three wavy lines representing snakes or ribbons intertwined around a central staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 1999

Ms. Karen Cain Regulatory Affairs Associate Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K990135/S1

Trade Name: Trilogy @ Acetabular System Longevity @ Crosslinked Polvethylene Liners Regulatory Class: II Product Code: LPH Dated: May 5, 1999 Received: May 7, 1999

Dear Ms. Cain:

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. 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 action. In addition, FDA may publish further announcements 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.

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Page 2 - Ms. Karen Cain

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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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# Exhibit AA

Page _ 1 _ of _ 2

510(k) Number (if known ___

K990135

Trilogy® Acetabular System Longevity® Crosslinked Polyethylene Device Name: Liners

Indications for Use:

The Trilogy® Acetabular System is indicated for either cemented or noncemented use in skeletally mature individuals undergoing surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

# See Next Page for 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 (Per 21 CFR 801.109) OR

Over-The-Counter Use _ (Optional Format 1-2-96)

RA01901K.510.DOC

Arally

Division Sign-Off livision of General Restorativ 490135 510(k) Number

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### WEAR CLAIMS

Trilogy Acetabular System Longevity® Crosslinked Polyethylene Liners showed an average 89 percent gravimetric wear reduction compared to the same cup conventionally gamma sterilized and both nonaged (final product after sterilization) and accelerated aged. The neutral liners (32 mm D/48 mm OD, 5.3 mm thickness and 22 mm ID/36 mm OD, 4.3 mm thickness) were made from compression molded, calcium stearate free UHMWPE were highly crosslinked, thermal stabilized, then gas plasma sterilized both nonaged (final product after sterilization) and accelerated aged. All control and crosslinked liners that were accelerated aged were subjected to 73 psi of oxygen at 70℃ for two weeks. Testing was performed to 5 million cycles using an AMTI hip simulator at 1 Hz, a cobalt-chrome articulating counterface, and bovine serum as lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

Trilogy Acetabular System Longevity Crosslinked Polyethylene Liners showed an average 89 percent gravimetric wear reduction compared to the same cup conventionally gamuna sterilized and accelerated aged when evaluated under abrasive wear conditions. The neutral liners (32 mm ID/48 mm OD, 5,3 mm thickness and 22 mm ID/36 mm OD, 4,3 mm thickness) were made from compression molded, calcium stearate free UHMWPE were highly crosslinked, thermal stabilized, and gas plasma sterilized. The liners were subjected to accelerated aging. Testing was performed to 3 million cycles using a Shore Western orbital-type hip simulator at 1Hz, a cobalt-chrome articulating counterface, and bovine serum as lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

Zimmer highly crosslinked, thermally stabilized UHMWPE, in both accelerated aged and nonaged (final product after sterilization) conditions, was evaluated by Electron Spin Resonance (ESR) spectroscopy to determine residual free radicals. The experimental detection limit is estimated to be 1013 spins/gram. In all cases, the residual free radical content was undetectable. Reduced levels of free radicals are associated with decreased oxidation of the material.

RA01901K.510.DOC

Picollyto

(Division Sign-Off) Division of General Restorative Devices K990135 510(k) Number

Prescription Use (Per 21 CFR 801.109)