(180 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance outlines wear reduction as the primary performance claim, specifically for the Trilogy® Acetabular System Longevity® Crosslinked Polyethylene Liners.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Wear Reduction | Average 89% gravimetric wear reduction compared to conventionally gamma sterilized and aged cups. |
| Residual Free Radicals | Undetectable, below the experimental detection limit of 10¹³ spins/gram. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes in-vitro testing, not studies involving human subjects or clinical data in the traditional sense. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they apply to clinical studies are not directly applicable here.
- Test Set Description: The "test sets" for the wear and residual free radical evaluations consisted of:
- Wear Testing: Neutral liners of specific dimensions (32 mm ID/48 mm OD, 5.3 mm thickness, and 22 mm ID/36 mm OD, 4.3 mm thickness) made from compression-molded, calcium stearate-free, highly crosslinked, thermal-stabilized, and gas plasma sterilized UHMWPE. Both non-aged (final product after sterilization) and accelerated-aged conditions were tested. The accelerated aging involved 73 psi of oxygen at 70°C for two weeks.
- Residual Free Radical Testing: Zimmer highly crosslinked, thermally stabilized UHMWPE in both accelerated-aged and non-aged conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This document details material testing (in-vitro wear and free radical analysis), not studies requiring human expert adjudication for ground truth. The "ground truth" here is the direct experimental measurement of material properties (gravimetric wear and free radical content).
4. Adjudication Method for the Test Set
Not applicable, as this was an in-vitro material testing study, not a study requiring human adjudication for interpretation of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is an a-clinical submission focused on material properties and wear performance, not a study involving human readers or clinical outcomes that would necessitate an MRMC design.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The studies described are standalone in that they involve the testing of the device material itself, independent of human interaction or interpretation beyond the setup and analysis of the experimental equipment. The "algorithm" in this context is the physical and chemical properties of the material and its performance under specific simulated conditions.
7. The Type of Ground Truth Used
The ground truth used in these studies is:
- Direct Experimental Measurement:
- Gravimetric Wear: Measured directly from the simulated hip environment.
- Residual Free Radicals: Measured directly using Electron Spin Resonance (ESR) spectroscopy.
8. The Sample Size for the Training Set
Not applicable. This submission describes pre-market testing of a medical device material, not a machine learning model that would require a "training set." The material itself is the "tested entity."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of a machine learning model. The wear data and free radical content are direct experimental results used to demonstrate the performance of the crosslinked polyethylene material.
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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: 219/372-4219 219/372-4605 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 -
{1}------------------------------------------------
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
{2}------------------------------------------------
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597, 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 ___
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)
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
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.(b)
Classification. Class II.