Cleared Special

K092443 - INTERFACE ACETABULAR CUP LINERS

K092443 is the FDA 510(k) clearance for INTERFACE ACETABULAR CUP LINERS by Omni Life Science, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 74-day FDA review.

K092443 · Omni Life Science, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
74d
Days
Class 2
Risk

K092443 is an FDA 510(k) clearance for the INTERFACE ACETABULAR CUP LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Omni Life Science, Inc. (Raynham, US). The FDA issued a Cleared decision on October 23, 2009 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Omni Life Science, Inc. devices

Submission Details

510(k) Number K092443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2009
Decision Date October 23, 2009
Days to Decision 74 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 445
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K092443.
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K093561 · Zimmer, Inc. · Apr 2010
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
K092098 · Smith & Nephew, Inc. · Jan 2010
TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT
K090897 · Howmedica Osteonics Corp. · Oct 2009
ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM
K091508 · Zimmer, Inc. · Sep 2009
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566 · Smith & Nephew, Inc. · Aug 2008
REVELATION HIP STEM, MODELS, 427-01, 427-02
K081679 · Encore Medical, L.P. · Aug 2008