(180 days)
Not Found
No
The summary describes a hip implant system and its wear properties, with no mention of AI or ML technology.
Yes
The device is an acetabular component for hip replacement surgery, used to rehabilitate hips damaged by various joint diseases, which aligns with the definition of a therapeutic device.
No
The device, the Trilogy Acetabular System, is an orthopedic implant (acetabular components for hip replacement surgery) used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a modular, acetabular component made of polyethylene liners, which are physical hardware components. The summary focuses on wear testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the Trilogy® Acetabular System as a component for hip replacement surgery. It is implanted directly into the patient's body to rehabilitate damaged hips.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is mechanical, providing a new articulating surface within the hip joint.
Therefore, based on the provided information, the Trilogy® Acetabular System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LPH
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human acetabulum
Indicated Patient Age Range
skeletally mature individuals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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 gamma sterilized and accelerated aged when evaluated under abrasive wear conditions. 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average 89 percent gravimetric wear reduction.
Residual free radical content was undelectable.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
3
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.
4
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
5
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
6
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)