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CI../..X Liner for NOVAE Dual Mobility Acetabular Cup

by Serf

510(k) K142675

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142675 Date15 Jan 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CI../..X liner for NovaE Dual Mobility Acetabular Cup is a device used in total hip replacement procedures. It is designed to work with the NovaE Dual Mobility Acetabular Cup, which is intended to enhance joint mobility and reduce dislocation risks. The device is classified under the product code LZO. The CI../..X liner is part of the orthopedic family of devices, specifically designed for use in hip replacement surgeries.

The CI../..X liner for NovaE Dual Mobility Acetabular Cup is supplied by Serf and has received FDA 510K authorization. The device is associated with the k number K142675 and has been reviewed by the Orthopedic advisory committee. It is designed for press-fit use and is intended for procedures such as osteoarthritis, femoral neck fracture, and revision procedures. The device is available with specific sizes and configurations, although exact details are not provided.

Other devices from Serf

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CI../..X liner for NovaE Dual Mobility Acetabular Cup used for?

    The CI../..X liner is used in total hip replacement procedures to work with the NovaE Dual Mobility Acetabular Cup, which is intended to enhance joint mobility and reduce dislocation risks. It is indicated for conditions such as osteoarthritis, femoral neck fracture, and revision procedures, as it supports press-fit implantation in hip arthroplasty.

  • How is the CI../..X liner supplied and is it sterile or single-use?

    The CI../..X liner is supplied by Serf and is intended for press-fit use, which implies it is provided as a sterile, single-use implant designed for implantation during surgery and not intended for reuse. This is standard for acetabular liners in joint replacement to ensure sterility and prevent wear or contamination.

  • What regulatory pathway was used for the CI../..X liner and what is its k number?

    The CI../..X liner received authorization through the FDA 510(k) pathway, as indicated by its k number K142675. It was found substantially equivalent to a predicate device, with a traditional clearance type, and was reviewed by the Orthopedic advisory committee after being received on September 19, 2014, and cleared on January 15, 2015.