Interface Acetabular Cup Liners
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092443 FDA 510(k)
- FDA Product Code
- LPH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3358 FDA 510(k)
- Regulation Number
- 888.3358 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Interface Acetabular Cup Liners are components of a modular acetabular cup system used in hip arthroplasty to replace the hip joint. They are designed for cementless fixation to bone and are intended to be combined with porous‑coated shells, polyethylene inserts, and optional screws as part of the OMNI Interface Acetabular System.
The liners are supplied for use with the OMNI Interface system and are covered by an FDA 510(k) clearance (special clearance, decision date 2009‑10‑23, product code LPH, K‑number K092443). They are intended for implantation in primary or revision hip procedures and are regulated as a Class II medical device under the listed authorizations.
Frequently asked questions
What is the Interface Acetabular Cup Liner used for?
The Interface Acetabular Cup Liner is used as a component in hip arthroplasty to replace the hip joint, designed for cementless fixation to bone and intended for use in primary or revision hip procedures as part of the OMNI Interface Acetabular System.
How is the Interface Acetabular Cup Liner supplied and what is it intended to be combined with?
The Interface Acetabular Cup Liner is supplied for use with the OMNI Interface system and is intended to be combined with porous-coated shells, polyethylene inserts, and optional screws as part of the modular acetabular cup system.
Is the Interface Acetabular Cup Liner intended for cemented or cementless fixation?
The Interface Acetabular Cup Liner is designed for cementless fixation to bone, as stated in the device description, and is not intended for use with bone cement.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Interface Acetabular Cup Liners - Omni Life Science - lavascular.com, PDF OMNIlife Traditional 510(k) for OMNI Interface Acetabular System, PDF Microsoft Word - IFU-025 rev E OMNI Interface Acetabular System IFU.doc
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092443 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OMNIlife science, Inc.
- FDA Applicant
- Omni Life Science, Inc.
Sources (1)
- FDA 510(k) K092443 24 fields · synced Sep 27, 2026