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Delta Dual Mobility System

by Lima Corporate S.P.A. 510(k)

Active United States

510(k) K181491

Overview

The Delta Dual Mobility System is a dual-mobility acetabular component designed for use in total hip arthroplasty. It combines a high-mobility polyethylene liner with a fixed femoral head to reduce dislocation risk while maintaining joint stability, as classified under orthopedic hip replacement devices.

This system is supplied as a sterile, single-use device and is intended for surgical implantation in the acetabulum. It is manufactured from Trabecular Titanium for cementless fixation and is regulated under FDA 510(k) clearance (K181491), with a product code of LZO. Storage and handling must comply with sterile medical device protocols.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181491 Date9 May 2019ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the primary clinical benefit of the Delta Dual Mobility System in total hip arthroplasty?

    The Delta Dual Mobility System is designed to reduce the risk of dislocation in total hip arthroplasty by combining a high-mobility polyethylene liner with a fixed femoral head. This dual-mobility design enhances joint stability while maintaining a wide range of motion, making it particularly useful for patients with higher activity levels or those at increased risk of dislocation.

  • Is the Delta Dual Mobility System reusable, or is it intended for single-use only?

    The Delta Dual Mobility System is explicitly supplied as a sterile, single-use device. This ensures patient safety and compliance with sterile medical device protocols, preventing cross-contamination and maintaining device integrity for one surgical procedure only.

  • What material is used for the acetabular component, and how is it fixed in place?

    The Delta Dual Mobility System is manufactured from Trabecular Titanium, a porous material that promotes cementless fixation in the acetabulum. This design allows for osseointegration with the patient’s bone over time, eliminating the need for bone cement.

  • How should the Delta Dual Mobility System be stored to maintain sterility?

    Since the Delta Dual Mobility System is sterile and single-use, it must be stored according to sterile medical device protocols. This includes keeping the packaging intact, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions to preserve sterility until use.

  • What regulatory pathway was followed for FDA clearance of this device?

    The Delta Dual Mobility System received FDA 510(k) clearance (K181491) under the Traditional Review pathway, classified as substantially equivalent to a predicate device. It falls under the Orthopedic (OR) Advisory Committee and is categorized under product code LZO (Orthopedic Hip Replacement Devices).