Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System, Trilogy Integrated Taper
by Zimmer, Inc.
510(k) K101229
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101229 | Date3 Dec 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Longevity It Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper
- 510(k) Number
- FDA Product Code
- LPH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are classified as Acetabular Components for Total Hip Arthroplasty (FDA Product Code: LPH). These devices are designed as modular acetabular cup liners made from highly crosslinked polyethylene, intended to reduce wear in total hip replacements. The Continuum and Trilogy Integrated Taper systems are modular acetabular cup systems that provide fixation to bone, with or without bone cement. The elevated liners are engineered to fit within these systems, enhancing stability and longevity in hip arthroplasty procedures.
These devices are supplied as single-use components for orthopedic surgery and are intended for use in total hip arthroplasty. The Continuum and Trilogy systems are modular, allowing customization of acetabular fixation. The Longevity IT liners are FDA-cleared under a Traditional 510(k) pathway (K101229) as substantially equivalent to a predicate device. They are not MRI-safe and must be stored in accordance with manufacturer guidelines to maintain sterility and integrity prior to use.
Other devices from Zimmer, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the Longevity IT Elevated Liners designed for?
The Longevity IT Elevated Liners are modular acetabular cup liners made from highly crosslinked polyethylene, specifically designed to reduce wear in total hip arthroplasty procedures. They are engineered to fit within the Continuum and Trilogy Integrated Taper systems, which provide modular fixation to bone—with or without bone cement—to enhance stability and longevity in hip replacements.
Are these liners reusable or single-use?
These liners are intended for single-use only. They are sterilized and packaged for one-time surgical use to ensure sterility and integrity. Reuse is not recommended or supported by the manufacturer, as it could compromise patient safety and device performance.
How do the Continuum and Trilogy systems differ in terms of fixation?
Both the Continuum and Trilogy systems are modular acetabular cup systems that allow for customization of acetabular fixation. The key difference lies in their design: the Continuum system is typically used for cemented fixation, while the Trilogy Integrated Taper system offers options for both cemented and cementless fixation. The Longevity IT Elevated Liners are compatible with both systems to provide flexibility in surgical planning.
What storage instructions should be followed to maintain sterility?
To maintain sterility and integrity before use, these liners must be stored in accordance with the manufacturer’s guidelines. This typically includes keeping them in their original, unopened packaging in a clean, dry environment, protected from moisture, heat, and direct sunlight. Avoid exposing them to contaminants or rough handling that could compromise their sterile field.
Are these liners MRI-safe?
No, these liners are not MRI-safe. Patients with these devices should avoid MRI scans, as the materials used may interact with magnetic fields, posing potential risks. Always confirm with the manufacturer or radiology department before any MRI procedure.