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OMNI Interface Acetabular System

by Omnlife Science

510(k) K142201

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 NumberK142201 Date26 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  • Withdrawn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
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
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 OMNI Interface Acetabular System is a modular acetabular component used in total hip arthroplasty. It is a cementless, single-use hip prosthesis for primary and revision total hip replacement. System components include titanium alloy acetabular shells (no-hole or 3-hole configurations), ultra-high molecular weight polyethylene (UHMWPE) shell inserts, and femoral heads.

The OMNI Interface Acetabular System is manufactured by Omnlife Science and classified as a Class 2 device under product code LPH. It was cleared through the FDA 510(k) pathway on January 26, 2015. The device is supplied as a single-use system and requires appropriate storage conditions as specified by the manufacturer.

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