← Product Code [KWZ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ) · K101730 # LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS (K101730) _Zimmer, Inc. · KWZ · Dec 3, 2010 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K101730 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [KWZ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ.md) - **Decision Date:** Dec 3, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3310 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in 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 Modular acetabular shell liner; captures femoral head to reduce joint dislocation risk. Features integral polyethylene fingers reinforced with modular Tivanium ring. Mates with Continuum and Trilogy IT acetabular shells. Used in primary or revision total hip arthroplasty. Operated by orthopedic surgeons in clinical/OR settings. Provides mechanical constraint to femoral head; prevents dislocation in high-risk patients. ## Clinical Evidence No clinical data provided. Substantial equivalence based on non-clinical bench testing, including head pull-out fatigue, rim impingement fatigue, static head pull-out, static rim impingement lever-out, liner locking mechanism strength, anatomic fatigue, constrained liner wear, liner durability, backside wear, and temperature effects. ## Technological Characteristics Modular acetabular liner; highly crosslinked polyethylene with integral fingers; Tivanium ring reinforcement. Mechanical constraint principle. Designed for use with Continuum and Trilogy IT acetabular shells. Non-active, mechanical device. ## 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 - Trilogy® Longevity Constrained Liner ([K071718](/device/K071718.md)) - Continuum™ and Trilogy Integrated Taper (IT) Acetabular Systems ([K091508](/device/K091508.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with the word "zimmer" written in a stylized font. Above the word, there is a circle containing a stylized letter "Z". The logo appears to be a company logo or brand mark. K101730 ### Summary of Safety and Effectiveness DEC - 3 2010 | Sponsor: | Zimmer. Inc.
P.O. Box 708
Warsaw, IN 46581-0708 | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Bradley W. Strasser
Associate, Regulatory Affairs
Telephone: (574) 372-4780
Fax: (574) 372-4605 | | Date: | 14 September 2010 | | Trade Name: | Longevity® IT Highly Crosslinked Polyethylene
Constrained Liner | | Common Name: | Total Hip Prosthesis | | Classification Name
and Reference: | Hip joint metal/polymer constrained cemented or
uncemented prosthesis.
21 CFR § 888.3310 | | Product Code: | K WZ - Prosthesis, Hip, Constrained, Cemented or
Uncemented, Metal/Polymer | | Predicate Device: | Trilogy® Longevity Constrained Liner,
manufactured by Zimmer, Inc., K071718, cleared
13 July 2007
Continuum™ and Trilogy Integrated Taper (IT)
Acetabular Systems, manufactured by Zimmer, Inc.,
K091508, cleared 11 September 2009 | | Device Description: | The Longevity Integrated Taper (IT) Constrained
Liner is a modular acetabular shell liner intended to
capture the femoral head of a total hip prosthesis to
reduce the incidence of joint dislocation. The liners
feature integral polyethylene "fingers" reinforced
with a modular Tivanium® ring to capture the
mating femoral head. The Longevity IT
Constrained Liners are intended to mate with | {1}------------------------------------------------ Page 2 Intended Use: Comparison to Predicate Device: Continuum and Trilogy IT acetabular shells. The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in 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. The Longevity IT Constrained Liners are manufactured from the same materials and processes as their predicates. The subject device also has the same intended use and constraining mechanism as the predicate Trilogy Longevity Constrained Liner. The Longevity IT Constrained Liners have the same liner locking mechanism as the predicate Continuum and Trilogy IT Acetabular System Polyethylene Liners. {2}------------------------------------------------ Page 3 #### Performance Data (Nonclinical and/or Clinical): Non-Clinical Performance and Conclusions: Non-Clinical testing was conducted on the proposed device per FDA's Guidance Document, "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis". This testing demonstrated that the Longevity IT Constrained Liners performed as intended and met all acceptance criteria. The Longevity IT Constrained Liner design and geometry were evaluated to demonstrate that the proposed device met performance requirements and is as safe and effective as its predicate. This information and testing data formed the basis for a determination of substantial equivalence. Specific Non-clinical Testing Completed: - Head Pull-Out Fatigue Test . - Rim Impingement Fatigue Test . - . Static Head Pull-Out Test - Static Rim Impingement Lever-Out Test t - Liner Locking Mechanism Strength . Analysis - . Anatomic Fatigue Analysis - Constrained Liner Wear Performance . - Liner Durability and Backside Wear . - Temperature Effects on Liner Assembly . - . Interaction of MRI with World Cup Implants Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized eagle or bird symbol, composed of three curved lines representing the wings and a wavy line representing the body. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zimmer, Inc. % Mr. Bradley W. Strasser Associate. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708 DEC - 3 2010 Re: K101730 Trade/Device Name: Longevity® IT Highly Crosslinked Polyethylene Constrained Liners 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: November 5, 2010 Received: November 8, 2010 Dear Mr. Strasser: 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {4}------------------------------------------------ Page 2 - Mr. Bradley W. Strasser 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark A. Milliman Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use K101730 DEC - 3 2010 # 510(k) Number (if known): Device Name: Longevity® IT Highly Crosslinked Polyethylene Constrained Liner #### Indications for Use: The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in 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) Janetta for mxm Division Sign Co. Division of Surgical, Orthopedic, and Resiorative Devices 510(k) Number K101730 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K101730](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K101730) **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. 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