(199 days)
P960054
Not Found
No
The device description focuses on the mechanical properties and design of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is a component of a total hip prosthesis, which is used to treat a medical condition (hip dislocation/instability), thereby fitting the definition of a therapeutic device.
No
The device is a component of a total hip prosthesis used in surgical procedures, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical implant made of polyethylene and titanium alloy, used in total hip arthroplasty procedures. It is a hardware component.
Based on the provided information, the Trilogy Constrained Liner is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a component of a total hip prosthesis used in surgical procedures for patients at high risk of hip dislocation. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical implant made of polyethylene and titanium alloy, designed to be surgically implanted into the hip joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
Therefore, the Trilogy Constrained Liner falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Trilogy Constrained Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
Product codes
KWZ
Device Description
The Trilogy Constrained Liner is a polyethylene liner assembly used in conjunction with a Trilogy Acetabular System metal shell in total hip arthroplasty procedures. The liner consists of two pieces: a liner and a constraining ring. The liner is manufactured from ultra-high molecular-weight polyethylene (UHMWPE) and the constraining ring is manufactured from Tivanium® Ti-6A1-4V Alloy.
The Trilogy Constrained Liner is offered with a 32mm internal diameter and 50-80mm outer diameter sizes. The inner diameter and face of the liner is oblique by 10 degrees resulting in offset and slight eccentricity between the internal and external diameter centers. This resultant offset acts to reduce soft tissue laxity and increase length which can contribute to joint instability. The 10-degree face can be rotated to reposition coverage opposite the direction of anticipated instability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
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)
Static assembly and lever-out evaluations indicated that this device would perform as intended and similar to other legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P960054
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a smaller, sans-serif font.
P. "1/2
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
Summary of Safety and Effectiveness
Submitted By:
DEC 2 0 2002
.
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 574-267-6131
Contact Person:
Karen Cain Manager, Regulatory Affairs Telephone: 574-372-4219 FAX: 574-372-4605
Date:
October 1, 2002
Trade Name:
Trilogy® Acetabular System Constrained Liner
Common Name:
Constrained Acetabular Liner
Classification Name:
Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis
Predicate Devices:
- Johnson & Johnson POLY-DIAL Constrained Acetabular Liner for the S-ROM -Total Hip System, P960054, approved June 19, 1997
1
Description:
The Trilogy Constrained Liner is a polyethylene liner assembly used in conjunction with a Trilogy Acetabular System metal shell in total hip arthroplasty procedures. The liner consists of two pieces: a liner and a constraining ring. The liner is manufactured from ultra-high molecular-weight polyethylene (UHMWPE) and the constraining ring is manufactured from Tivanium® Ti-6A1-4V Alloy.
The Trilogy Constrained Liner is offered with a 32mm internal diameter and 50-80mm outer diameter sizes. The inner diameter and face of the liner is oblique by 10 degrees resulting in offset and slight eccentricity between the internal and external diameter centers. This resultant offset acts to reduce soft tissue laxity and increase length which can contribute to joint instability. The 10-degree face can be rotated to reposition coverage opposite the direction of anticipated instability.
Intended Use/Indications for Use
The Trilogy Constrained Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
Comparison to Predicate Devices
The acetabular cup listed above is substantially equivalent to the Trilogy Constrained Liner in that both are intended to replace the bearing surface of the acetabulum in patients at high risk of dislocation. The predicate device, as well as the Trilogy Constrained Liner, is manufactured from UHMWPE and features a constraining ring made of titanium alloy which is assembled by the surgeon at the time of surgery. Static assembly and lever-out evaluations indicated that this device would perform as intended and similar to other legally marketed devices.
RA092500K.LT
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, representing health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Cain Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 .
Re: K021826
Trade/Device Name: Trilogy® Acetabular System Constrained Liner Regulation Number: 21 CFR 888.3310 1 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: October 1, 2002 Received: October 3, 2002
Dear Ms. Cain:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Karen Cain
This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
fo Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit K
Page 1 of 1
510(k) Number (if known
02182
Device Name:
Trilogy® Acetabular System Constrained Liner
Indications for Use:
The Trilogy Constrained Liner is indicated for either cemented or noncemented use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
RA06201K.510
íriam C. Provost
sion of General, Restorative d Neurological Devices
Ko21826