← Product Code [KWZ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ) · K071718 # TRILOGY LONGEVITY CONSTRAINED LINER (K071718) _Zimmer, Inc. · KWZ · Jul 13, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K071718 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [KWZ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ.md) - **Decision Date:** Jul 13, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3310 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Trilogy® Longevity® Constrained Liner is indicated for primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. ## Device Story Trilogy Longevity Constrained Liner is a polyethylene/metal acetabular liner component for total hip prostheses; used with Trilogy or Trabecular Metal Modular Acetabular Shells. Device comprises Longevity Highly Crosslinked Polyethylene liner and Tivanium alloy constraining ring. Mechanical capture of metal femoral head provides greater flexion/extension range of motion compared to hooded constrained liners. Designed for patients at high risk of hip dislocation. Implanted by surgeons during primary or revision total hip arthroplasty. Modification of Epsilon Durasul Constrained Acetabular Liner; features updated material, finger/ring design for assembly, and modified backside for shell compatibility. ## Clinical Evidence No clinical data provided; substantial equivalence supported by non-clinical mechanical testing. ## Technological Characteristics Acetabular liner consisting of Longevity Highly Crosslinked Polyethylene and Tivanium alloy constraining ring. Designed for use with modular acetabular shells. Mechanical capture mechanism for femoral head. ## Regulatory 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). ## Special Controls *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.” ## Predicate Devices - Zimmer (formerly Centerpulse) Epsilon Durasul Constrained Acetabular Liner ([K030923](/device/K030923.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 长071718 ### Summary of Safety and Effectiveness : ## JUL 1 3 2007 | Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Stephen McKelvey, MA, RAC
Senior Manager, Corporate Regulatory Affairs
Telephone: (574) 372-4944
Fax: (574) 372-4605 | | Date: | June 20, 2007 | | Trade Name: | Trilogy ® Longevity ® Constrained Liner | | Common Name: | Constrained Acetabular Liner | | Classification Names
and References: | 21 CFR 888.3310: Hip joint metal / polymer
constrained cemented or uncemented prosthesis,
Product code: KWZ | | Predicate Device: | Zimmer (formerly Centerpulse) Epsilon ™ Durasul ®
Constrained Acetabular Liner, K030923, cleared
October 3, 2003 | | Device Description: | The Trilogy Longevity Constrained Liner is a
polyethylene/metal acetabular liner, which, when
used with a Trilogy or Trabecular Metal ™ Modular
Acetabular Shell, forms the acetabular component
of a total hip prosthesis. The device consists of a
Longevity Highly Crosslinked Polyethylene Liner
and a Tivanium ® alloy constraining ring.

The liner allows for mechanical capture of the metal
femoral head and greater flexion/extension range of
motion than hooded constrained liner designs. | | Intended Use: | The Trilogy Longevity Constrained Liner is
indicated for primary or revision total hip
arthroplasties where there is a high risk of hip
dislocation due to a history of instability, bone loss,
joint, muscle or tissue laxity, or disease condition. | . . . . {1}------------------------------------------------ This device is intended for patients for whom all other options to constrained acetabular components have been considered. The Trilogy Longevity Constrained Liner is a design modification of the Epsilon Durasul Constrained Acetabular Liner. The material has been changed to Longevity Highly Crosslinked Polyethylene, the finger and ring designs have been modified to ease assembly and the backside has been modified for use with Trilogy and Trabecular Metal Modular Acetabular Shells. #### Performance Data (Nonclinical and/or Clinical): Comparison to Predicate Device: Non-Clinical Performance and Conclusions: Mechanical testing of the modified device indicates that it is substantially equivalent to the predicate. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. {2}------------------------------------------------ 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 13 2007 Zimmer, Inc. % Mr. Stephen McKelvey, MA, RAC Senior Manager, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708 Re: K071718 Trade/Device Name: Trilogy® Longevity® Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: June 20, 2007 Received: June 22, 2007 Dear Mr. McKelvey: We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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 {3}------------------------------------------------ Page 2 - Mr. Stephen McKelvey, MA, RAC forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrl/industry/support/index.html Sincerely yours, Mark McMillan Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K071718 Device Name: Trilogy® Longevity® Constrained Liner #### Indications for Use: The Trilogy® Longevity® Constrained Liner is indicated for primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Munk A. Milken (Division Sign-Off (Division of General, R Division of States and Neurological De 510(k) Number Page 1 of 1 022 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K071718](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K071718) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com